Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It's an epidemic people. Read this its happening everywhere!
Ontario Health Minister is Right; Social Cost of Generic OxyContin Abuse Exceeds Price Savings by Up to $415 Million Annually
TORONTO, ONTARIO–(Marketwire – Sept. 12, 2012) - Generic drug companies are seeking approval from Health Canada to sell discontinued abuse-prone formulations of the prescription drug OxyContin. OxyContin was replaced earlier this year with a new abuse-deterrent formulation called OxyNEO. Ontario’s Health Minister Deb Matthews recently asked her federal counterpart not to approve generic OxyContin because the older formulation is prone to abuse, which causes social costs that outweigh expected generic price savings. New research published today by the Canadian Health Policy Institute (CHPI) suggests Matthews is right – the avoidable costs of OxyContin abuse could exceed the savings expected from generic prices by up to $415 million annually.
OxyContin is a controlled-release version of the opioid-derived prescription drug oxycodone. Abusers modify the drug by crushing tablets for inhaling or dissolving the tablets in fluid for injecting, which defeats the time-release property that moderates the dosage. While OxyContin is an effective pain reliever for millions of people, abuse of the product is associated with significant social costs including addiction rehabilitation, medical care, criminal justice and lost productivity.
Earlier this year, the manufacturer stopped selling the old abuse-prone version of OxyContin and replaced it with a new abuse-deterrent formulation called OxyNEO, which is resistant to crushing and dissolving. The substitution of OxyNEO for OxyContin has the potential to greatly reduce abuse while preserving health benefits for millions of legitimate users. But generic drug companies are now seeking Health Canada’s approval to sell the old version of OxyContin once its patent expires.
In a June 6, 2012 letter, Ontario’s Health Minister Deb Matthews asked Federal Health Minister Leona Aglukkaq not to approve generic versions of OxyContin stating, “Ontario believes that the costs to society of the reintroduction of the more-easily abused version far outweigh the financial benefits that would accrue from the reduced price”.
The CHPI study examined the economic impact of withholding generic approval, which would result in permanent withdrawal of the abuse-prone version and full substitution with the new abuse-deterrent OxyNEO formulation. The findings were published in CHPI’s online journal Canadian Health Policy.
The study calculates that for 2011 the annual social costs from OxyContin abuse could be as high as $504 million in Canada and $318 million in Ontario, while the annual savings expected from generic discounts on OxyContin across Canada would have ranged between $89 million and $152 million. In Ontario, corresponding generic savings estimates ranged between $52 million and $106 million.
For Canada, potentially avoidable costs outweigh expected generic savings by between $352 million and $415 million annually. OxyNEO substitution would need to reduce prescription drug abuse by as little 18 percent to 30 percent for the trade-off between allowing and prohibiting generic versions to be economically neutral.
The study was authored by Brett Skinner, Founder and CEO of CHPI. According to Skinner, “the available evidence suggests that generic Oxy would exacerbate social costs that could be avoided to a significant degree by substitution of the new abuse-deterrent formulation OxyNEO. Avoidable costs very likely exceed expected generic price savings. Most of the costs of OxyContin abuse are paid for directly or indirectly by governments – and therefore by taxpayers. Ontario’s Minister of Health is likely correct, if Health Canada approves cheap generic Oxy it could end up costing us plenty.”
About CHPI
Established in 2012, Canadian Health Policy Institute (CHPI) is a federally incorporated non-profit, independent think-tank. CHPI is dedicated entirely to conducting, publishing and communicating evidence-based socio-economic research on health system performance and health policy issues that are important to Canadians. CHPI’s work is published in the online journal Canadian Health Policy, www.canadianhealthpolicy.com.
2012-09-12 04:43:37
Source: http://www.marketwire.com/mw/release.do?id=1700330&sourceType=3
Interesting read on Remoxy "worth BILLIONS" relates to Elites potential in the near future!
------------------------------------------------------------------
Report: Pfizer Resubmission of Remoxy NDA Would Mean Big Upside For PTIE
Analysts and investors are refocusing on the opportunity for Pain Therapeutics’ (NASDAQ:PTIE) lead drug candidate, Remoxy. Remoxy is an extended-release formulation of the widely used painkiller oxycodone, similar to blockbuster drug Oxycontin. However, Remoxy is also designed to reduce the risk of opioid abuse, a major public health problem. Analysts estimate that Remoxy has the potential to achieve annual sales in the billion-dollar range, as pain medications are the third largest category of drugs sold in the U.S. based on the number of prescriptions. Last year, there were 238 million prescriptions filled for opioid-based pain medicines like oxycodone in the U.S., according to IMS Health. However, Remoxy has been rejected twice for approval by the FDA. As a result, doubt over the drug getting to market has caused PTIE shares to trade at depressed levels, providing investors with an opportunity to take advantage of recent events that support the drug’s chances of commercialization.
Pain Therapeutics and its development and marketing partner King Pharmaceuticals received their first Complete Response Letter (CRL) from the FDA in December 2008. A CRL is essentially a rejection by the FDA, with information on what is needed to re-apply. Based on the CRL, PTIE and King were required to answer questions posed by the agency before an approval could be granted. PTIE and King responded to the FDA and resubmitted their New Drug Application (NDA) for the product in December 2010. While the FDA evaluated the application, mega drug company Pfizer, Inc. (NYSE:PFE), acquired King in March 2011. That June, a new CRL was issued, requiring more answers from the drug sponsors. Importantly, neither CRL required additional clinical trials to be conducted for the drug’s efficacy, safety, or its ability to reduce the chance of abuse. In fact, Phase III trials demonstrated that Remoxy provided round-the-clock pain relief, and in a separate study, the drug’s formulation resisted ‘dose-dumping’ (a quick and intense high that drug abusers seek by binge drinking and also taking narcotics). The key outstanding issues for approval, according to PTIE, center primarily on product manufacturing questions.
With Pfizer now in charge of addressing the FDA’s concerns, the chance for a Remoxy approval has risen significantly, given Pfizer’s vast resources and experience in drug development. In addition, PFE’s industry-leading marketing and sales resources also suggest that, if approved, Remoxy could become a blockbuster product in the pain treatment market. But the first question on investor’s minds is: How committed is Pfizer to the drug after two FDA rejections? To be sure, if Pfizer drops the project and returns Remoxy’s marketing rights to PTIE, investors will lose faith in the drug’s prospects and shares of PTIE will decline in suit. A partial offset to this risk is that about half of PTIE’s market value is in cash, meaning that PFE walking away from the deal could cause the shares to lose roughly 50% of their value. This overhang is well-known and already discounted into the stock, therefore, the first step to realizing a profit in PTIE is confirmation that Pfizer is fully committed to Remoxy’s approval and commercialization. PTIE shares look very attractive from a risk/reward standpoint, which we explain below.
Expect Pfizer To Meet With the FDA About Remoxy in October
Pfizer’s early and more recent actions demonstrate that the big pharma firm is dedicated to Remoxy’s success. For instance, despite the second FDA rejection shortly after Pfizer acquired King (and rights to Remoxy), there have been numerous opportunities for the pharmaceutical giant to abandon the project. Notably, Pfizer has merged with other major pharmaceutical companies – Wyeth most recently in 2009 – and has been focused on streamlining operations to lower operating costs. Many drug development projects have been cut over the years, yet Remoxy remains in Pfizer’s late-stage pipeline. In fact, on its earnings call following the FDA’s rejection of Remoxy in August 2011, Pfizer CEO Ian Reed stated that the company saw getting Remoxy to market as a when, not if question. While the companies have not specifically stated what the FDA required in its latest CRL, Pfizer initiated two clinical trials, one evaluating how Remoxy behaves in the body at different dosages and the other testing behavior of the drug in the body at different time intervals after a dose is taken. The resources devoted to these studies (seen onwww.clinicaltrials.gov as Trial NCT01552850 and Trial NCT01552863, respectively) certainly indicate Pfizer’s commitment to gaining approval of Remoxy. Based on earlier comments from PTIE that certain batches of Remoxy showed inconsistent drug release performance during in vitro (in the lab) tests, it appears that the Pfizer clinical trials seek to demonstrate the manufacturing consistency of Remoxy and how these data relate to the consistency of the drug in vivo (in patients).
The first trial, NCT01552850, completed in June, and results from the second trial are currently being evaluated by Pfizer. Pfizer is not expected to publicly release results from these studies, but on its most recent earnings call with investors, Pfizer’s President and General Manager of Specialty Care and Oncology, Geno Germano, said:
“We remain cautiously optimistic to be able to bring Remoxy to the marketplace. We have preliminary results from two bioavailability studies that are currently being analyzed along with data from experiments designed to optimize the formulation composition and our analytical methods for that product. And upon completion of those analyses we will determine the timing and the nature or our engagement with the FDA to address the complete response letter that we received in June last year and at this time we are certainly hoping to meet with the FDA in the fourth quarter of 2012.”
Importantly, Pfizer spent time talking about Remoxy on the conference call, and given that the new Remoxy studies have completed, those comments were likely made with much of the trial results in hand. Assuming that PFE requests to meet with the FDA in September (meetings are scheduled no more than 30 days following a request), Pfizer and the agency could discuss results and resubmission potential in October. Should the meeting go well and a path to re-filing Remoxy’s NDA is made clear, Pfizer and Pain Therapeutics are likely to announce the news, sending shares of PTIE higher.
Remoxy Fits Pfizer’s Long-Term Strategy
Strategically, Pfizer has sold, or is planning to sell, non-core businesses like its Consumer and Animal Health divisions to raise cash in order to return value to shareholders through stock buybacks and dividends. The company points to a focus on its “innovative core,” meaning pharmaceutical and biotechnology products. Pfizer wants to see Remoxy through to market as the product fits with its long-term strategy. Also highly important for Pfizer, Remoxy has new patents protecting the formulation from potential generic competition through 2025. Other barriers to entry exist, evidenced by the challenge to consistently manufacture the product, as well as the likelihood that the FDA could require would-be generic companies to run clinical trials and abuse potential studies, as was done with Remoxy. These barriers are extremely attractive to major pharmaceutical companies, which have seen their businesses topple due to generic competition.
Large Market Opportunity For Remoxy
If Pfizer’s NDA is approved this third time around, Remoxy will be entering a valuable marketplace. Analysts expect the opioid market to grow from $11 billion in 2011 to $15.3 billion by 2016. Remoxy’s closest competitor, Oxycontin (sold by Purdue Pharma), has worldwide sales of nearly $4 billion annually, and analysts anticipate Remoxy could grab significant share of Oxycontin’s market. With its tamper-resistant formulation, doctors’ familiarity with the active ingredient (oxycodone), and one of the world’s largest pharmaceutical companies backing the product, investors expect this drug to be a multi-billion dollar product once approved. The first $1 billion in Remoxy sales is worth $150 million in annual revenues to Pain Therapeutics. At typical small-tier pharma valuations (4x sales), these revenues would value PTIE at $600 million (plus cash), more than triple the stock’s current valuation. We note that the upside could be much larger if the drug can achieve more than $1 billion a year in sales (royalty to PTIE goes up from 15% to 20% for sales above $1 billion). As a result, Pfizer announcing that it believes the FDA has given it a clear path to re-file Remoxy in the U.S should unlock considerable value. In fact, a doubling of the price of PTIE on such news should not be a surprise.
Tamper-Resistance Addresses An Important Market Need
Back in 2008, when the original Remoxy NDA was filed, the FDA not only accepted the application, but granted the drug Priority Review. Priority Review means that the agency has agreed to an accelerated path for approval – review timeline of six months rather than ten – and indicates that the FDA is convinced that the drug offers a significant advance over existing products. As mentioned earlier, abuse-resistant technology provides a substantial barrier to entry for generic competition because of costs to develop adequate tamper-resistant formulations and the potential challenges of mass manufacturing such products. The FDA is increasing regulations governing controlled substances as evidenced by legislation like the Stop Tampering of Prescription Pills Act. It is likely that simple, cheap bioequivalence studies will be a thing of the past when generic producers seek to apply for formulations of opioid-containing medicines. In addition to the backing, and the barriers, provided by the FDA, doctors are also expected to favor Remoxy’s abuse-resistant qualities vs. market leading pain medicine, Oxycontin. Oxycontin has no tamper-resistance technology in its formulation, and became implicated as a key contributor to the rise of opioid abuse when in 2009, Rush Limbaugh turned himself in for addiction to the drug. According to the U.S. Centers for Disease Control and Prevention (CDC), there’s a strong correlation between rising prescription painkiller sales and rising deaths related to painkiller overdoses, which increased nearly 400% from 1999 to 2008. Attacking the stigma associated with writing a prescription for Oxycontin could be a key marketing tactic for Pfizer in its promotional campaign for Remoxy.
PTIE and Durect Positioned For Big Rewards Or Pfizer May Move Towards Acquisition
Built into its licensing arrangement with King Pharmaceuticals – the original Remoxy licensee – is a generous royalty agreement for Pain Therapeutics. The company is entitled to receive 15% of Remoxy’s first $1 billion in revenue annually, followed by 20% of all sales over $1 billion in a given year. Generous, in fact, only begins to describe the revenue opportunity for PTIE. In addition to the steep royalty to PTIE, Pfizer must also reimburse Pain Therapeutics for payments to Durect Corporation (NASDAQ:DRRX), the company that created the abuse-resistant technology behind Remoxy and licensed it to PTIE. The royalty to DRRX is between 6%-11%, depending on sales levels, meaning that Pfizer may have to pay up to 31% of sales in combined royalties to these smaller companies. If Remoxy becomes a blockbuster drug, it is highly unlikely that PFE will pay this freight, and more than likely will buy out both companies to keep all the profits. The sooner the better for Pfizer, as both PTIE and DRRX are likely to become more expensive as Remoxy approaches commercialization. Assuming Pfizer gets a favorable nod by the FDA for Remoxy’s filing and approval potential, the market may start to build in take-out premiums in both PTIE and DRRX’s share price.
The economics of Remoxy’s approval – strong royalties with little risk – provide significant upside for PTIE from current levels. Analyst price targets call for the stock to reach $10 over the next 12 months. Downside risk in PTIE is limited by its strong balance sheet; the company has approximately $94 million in cash and investments – half of PTIE’s market capitalization – and expects to use just $5 million to fund operations for the remainder of 2012 (company guidance is for cash use of <$10 million for full year 2012). Profiting from PTIE is a staged process, beginning with more certainty about Pfizer moving forward to resubmit Remoxy’s NDA. Pfizer’s actions thus far illustrate a strong commitment to Remoxy, and PTIE (and DRRX indirectly) shares are expected to begin reflecting the drug’s potential this fall as Pfizer’s meeting with the FDA approaches.
It's Official Guy's Ive Broke Even NOW!
Time to really get excited!
How long would it take to get fired up with the new facility?
After the decision is made?
Let's not forget the $4.50 one year target price
Here guy's. It is very possible indeed!
We don't need revenues for a PPS spike
All we need is news of drugs coming to market with a future speculation as to possible revenues. JMO
Let's all take a moment and remember those lost 9/11/2001
Let's not forget those still responsible are still among us!
couch i AGREE The STOPP aCT IS IT!
lIKE mj THiS is it!
The fire has been lit
Now that more and more pain management facilities and doctors are being raided and prosecuted by the DEA, eyebrows are being lifted at the big pharma and their profit margins are being examined.
The question is, extend the research money or just buy small companies that see the future and invest in the right patents they shunned thinking they could keep going? This is a drug cartel people. Keep that in mind. These companies make billions and if they didn't see the left turn signal, they will seek it out. That's the game changer! ELI-216
Why have large Pharma been SLOW on Abuse resistant drugs?
To answer that question in the most simplistic form would be to say that large companies like Purdue would like to appear that they are accomplishing something with abuse resistant drugs, while at the same time still delivering a product that can be compromised and abused. Why would they do this? Because the campaign of pain management has made them billions of dollars and they want to slow the process while still allowing people to abuse the very drugs they manufacture.
ELITE has no obligation to huge board members that want to keep America high and keep the numbers in their favor like big pharma. Big pharma is going to have a huge wake up call as the FDA hammers it home and more and more doctors are prosecuted. Large pharma has created an almost underground drug trafficking cartel feel to their operating procedures that will surely be like shooting themselves in the foot.
NO ONE, I repeat no company has the revolutionary two bead technology that Elite has nor have they put forth the energy to create a real abuse proof product because they want to put it off as long as possible based on their billion dollar profits and still deliver a compromised formulation that can still be extracted to get high.
The government hammer will swing hard soon as insurance companies are getting sick and tired of supporting opioid habits and the government is tired of vetting the bill. Big pharma CEO's are going to loose this one I guarantee it!
Why ELI-216 is a game changer for abuse resistant technology
Effect of current available Abuse-Deterrent Formulation of OxyContin lacks abuse resistance
in August 2010, an abuse-deterrent formulation of the widely abused prescription opioid OxyContin was introduced. The intent was to make OxyContin more difficult to solubilize or crush, thus discouraging abuse through injection and inhalation. We examined the effect of the abuse-deterrent formulation on the abuse of OxyContin and other opioids.
Data were collected quarterly from July 1, 2009, through March 31, 2012, with the use of self-administered surveys that were completed anonymously by independent cohorts of 2566 patients with opioid dependence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, who were entering treatment programs around the United States and for whom a prescription opioid was the primary drug of abuse (i.e., heroin use was acceptable but could not be the patient's primary drug). Of these patients, 103 agreed to online or telephone interviews to gather qualitative information in order to amplify and interpret findings from the structured national survey.
As shown in Figure 1AFigure 1Effect of Abuse-Deterrent OxyContin., the selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse-deterrent formulation to just 12.8% 21 months later (P<0.001). Simultaneously, selection of hydrocodone and other oxycodone agents increased slightly, whereas for other opioids, including high-potency fentanyl and hydromorphone, selection rose markedly, from 20.1% to 32.3% (P=0.005). Of all opioids used to “get high in the past 30 days at least once” (Figure 1B), OxyContin fell from 47.4% of respondents to 30.0% (P<0.001), whereas heroin use nearly doubled.
Interviews with patients who abused both formulations of OxyContin indicated a unanimous preference for the older version. Although 24% found a way to defeat the tamper-resistant properties of the abuse-deterrent formulation, 66% indicated a switch to another opioid, with “heroin” the most common response. These changes appear to be causally linked, as typified by one response: “Most people that I know don't use OxyContin to get high anymore. They have moved on to heroin [because] it is easier to use, much cheaper, and easily available.” It is important to note that there was no evidence that OxyContin abusers ceased their drug abuse as a result of the abuse-deterrent formulation. Rather, it appears that they simply shifted their drug of choice.
Our data show that an abuse-deterrent formulation successfully reduced abuse of a specific drug but also generated an unanticipated outcome: replacement of the abuse-deterrent formulation with alternative opioid medications and heroin, a drug that may pose a much greater overall risk to public health than OxyContin. Thus, abuse-deterrent formulations may not be the “magic bullets” that many hoped they would be in solving the growing problem of opioid abuse.
Theodore J. Cicero, Ph.D.
Matthew S. Ellis, M.P.E.
Washington University in St. Louis, St. Louis, MO
cicerot@wustl.edu
Hilary L. Surratt, Ph.D.
Nova Southeastern University, Coral Gables, FL
Supported by the Denver Health and Hospital Authority, which provided an unrestricted research grant to fund the Survey of Key Informants' Patients (SKIP) Program, a component of the RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance) System.
Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.
This letter was updated on July 12, 2012, at NEJM.org.
Senate Report: Prescription Drug Abuse One of Biggest Drug Policy Threats Facing US
A new Senate report highlights the growing problem of prescription drug abuse, calling into question the conventional wisdom that drug cartels in Latin America should be the major focus of US drug policy, The Christian Science Monitor reports.
According to the report from the Senate Caucus on International Narcotics Control, the Office of National Drug Control Policy views prescription drug abuse as the nation’s fastest growing drug problem. The report states that overdose deaths from prescription painkillers now outnumber deaths involving heroin and cocaine combined, accounting for 20,044 of 36,450 overdose deaths in the US in 2008. The number of people seeking treatment for addiction to legal opiates increased 400 percent between 2004 and 2008.
Prescription drug abuse is also leading to increased violent robberies of pharmacies, making it a security issue as well as a health issue.
Use of marijuana and cocaine appears stable. The findings in the report indicate that Latin American drug cartels are less important than they once were in fueling drug abuse in the United States, the newspaper notes. They are not major suppliers of prescription drugs; a government survey found 70 percent of people abusing prescription drugs got their pills from a relative or friend.
“The epidemic raises the tricky question of just how many resources the US should continue putting into international drug enforcement in Latin America, when it’s clear that the more pressing challenges facing the country lie within its own borders and its domestic laws regarding pharmaceutical drugs,” the article states.
STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/07/stopp-act-would-establish-new-requirements-for-tamper-resistant-drugs.html
By Kurt R. Karst –
Last week, Representative William Keating (D-MA) announced the introduction of new legislation – the Stop Tampering of Prescription Pills Act of 2012, or STOPP Act (H.R. 6160) – that is intended to direct companies “to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature that already employ tamper resistant technologies.” Although Congress has, over the years, encouraged companies to develop drug products with tamper- or abuse-resistant characteristics and has issued certain directives to FDA with respect to such products (see here, page 142; here, page 102; and here, page 81), including directing FDA to issue guidance on the development of abuse-deterrent drug products as part of the recently enacted FDA Safety and Innovation Act (§ 1122), the STOPP Act goes much further.
The STOPP Act would amend the FDC Act to, among other things, establish new requirements for the approval of brand-name and generic drugs that are otherwise available in a tamper-resistant formulation. Specifically, under the STOPP Act:
• If a pharmaceutical manufacturer submits an [ANDA] to [FDA] that refers to a listed drug that utilizes a tamper resistant formulation, the application must include data demonstrating that the new drug is tamper resistant to a degree comparable to the listed drug. If the ANDA does not make such a showing, FDA must refuse approval of the application.
• FDA must refuse approval of a [NDA] for a new drug, which is an oral dosage form, that contains a controlled substance as an active ingredient and does not utilize a tamper resistant or abuse deterrent formulation, where FDA has previously approved a drug that: (1) is an oral dosage form, (2) contains the same controlled substance as an active ingredient, (3) utilizes a tamper resistant or abuse deterrent formulation, and (4) has not been discontinued from marketing.
• If a listed drug begins to utilize a tamper resistant formulation, any drug previously approved under an ANDA that refers to such listed drug must be deemed not therapeutically equivalent – and thus not substitutable – to the listed drug, unless and until the generic also begins to utilize a tamper resistant formulation.
• If approval of a listed drug has been withdrawn, or if such drug is withdrawn from sale, after a tamper resistant version of that drug has been approved under another NDA, then such drug shall be considered withdrawn from sale for a safety reason.
• FDA must refuse a suitability petition where the petition references a listed drug that utilizes an abuse deterrent formulation, and the new drug contains any active ingredient(s) that differ in any respect from those contained in the listed drug. As a result, any such new drug must be approved under an NDA rather than an ANDA.
One example cited by Rep. Keating as a basis for the STOPP Act is the tamper-resistant version of Purdue Pharma L.P.’s OxyContin (oxycodone hydrochloride) Controlled-Release Tablets that FDA approved in April 2010 under NDA No. 022272 and that replaced the original and now discontinued non-tamper-resistant version of the drug FDA approved in December 1995 under NDA No. 020553. FDA has already received several citizen petitions (Docket Nos. FDA-2011-P-0473, FDA-2010-P-0540, and FDA-2010-P-0526) requesting that the Agency determine whether the discontinued version of OxyContin was voluntarily withdrawn for safety or effectiveness reasons. FDA’s decision on the issue will determine whether the agency can approve any pending ANDAs for the discontinued formulation.
More recenty, and just a week prior to the introduction of the STOPP Act, Purdue submitted a 75-page citizen petition to FDA (Docket No. FDA-2012-P-0760) requesting that the Agency, among other things, issue guidance detailing the in vitro and in vivo tests that must be performed by the sponsor of an ANDA for a generic version of the tamper-resistant version of OxyContin “to characterize the physicochemical properties of the proposed generic product and to assess the release of oxycodone when the product is manipulated in order to simulate attempts to tamper with the product for purposes of abuse or misuse,” and to refuse to approve any ANDA that does not meet such standards. In July 2010, FDA issued draft guidance specifying the types of bioequivalence studies the Agency recommends for generic versions of the tamper-resistant version of OxyContin; however, the draft guidance makes no mention of studies taking into account tamper resistance. More recently, FDA issued draft bioequivalence guidance with respect to generic versions of EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules that includes a crush study that “allows for the assessment of Naltrexone bioequivalence in a potential abuse situation.”
Who has Ameritrade?
I set up an account for think or swim like a month ago but haven't funded my account. My current brokerage charges me an arm, leg and shoulder for BB stocks. Can I just transfer my account over without any large fees with my stock's in-tacked? I haven't looked into it it yet just though I'd ask. TIA
Way to go jpc7330
We should all do this everyday all week!
Anatomy of an Epidemic: The Opioid Movie
http://www.youtube.com/watch?v=10ZlSSXiuP4
By John Fauber, Milwaukee Journal Sentinel/Medpage Today and Ellen Gabler, Milwaukee Journal Sentinel
Published: September 09, 2012
Driving home from a hunting trip in 2008, Johnny Sullivan called his wife to say he was having trouble staying awake.
It was early afternoon, but Mary Lou Sullivan wasn't surprised. Her husband was a long-time user of the narcotic painkiller OxyContin (oxycodone) and frequently dozed off as a side effect,sometimes in the middle of chewing his food.
About 10 years earlier, Sullivan and six other chronic pain sufferers had been featured in a Purdue Pharma promotional video for the drug, which Purdue makes. In the video, Sullivan stood at a construction site and talked about how the powerful narcotic eased his back pain and enabled him to run his company again.
But a few years after being prescribed OxyContin, Sullivan became addicted to it and other prescription opioids, his family said. That afternoon in 2008, Sullivan, 52, fell asleep while driving and flipped his truck on a country road in North Carolina.
"I told my sons one day 'that medicine is going to kill him,'" his widow said.
Expanding the market
Purdue Pharma's marketing of OxyContin in the late 1990s marked the beginning of the industry's push to promote narcotic painkillers for treatment of chronic pain -- an indication for which both safety and efficacy remain unproven.
The first decade of the 21st century has been a good one for makers of prescription painkillers as sales quadrupled from 1999 through 2010, but even in a growth industry OxyContin stands out -- ringing up sales of nearly $3 billion a year.
Meanwhile, health officials and regulators have declared a national epidemic as addictions to prescription painkillers have skyrocketed and fatal overdoses have more than tripled in the past decade.
A U.S. Senate investigation -- prompted in part by Journal Sentinel/MedPage Today reports -- is probing financial relationships of drug companies and the doctors and organizations that have advocated for use of the drugs.
Against that background, the Purdue promotional video emerges as a case study of marketing running ahead of science in the pursuit of the bottom line.
The video, made 14 years ago, showcased ordinary people who spoke glowingly of their experiences with OxyContin.
· Two of the seven patients died as active opioid abusers.
· A third became addicted, suffered greatly, and quit after realizing she was headed for an overdose.
· Three patients still say the drug helped them cope with their pain and improved their quality of life.
· A seventh patient declined to answer questions.
The doctor who not only played a starring role but also recruited his patients for the video now concedes some of his statements caught by the camera went too far.
In the video, the doctor, Alan Spanos, MD, a paid specialist in North Carolina, urged doctors to consider prescribing opioids more often.
Spanos, who was once a paid promotional speaker for Purdue, now says the video was meant to be one teaching aid used in lectures by experienced doctors.
But it was unclear then, and remains unclear now, what percentage of patients benefit from the drugs.
"We don't know whether success stories like this are one in five, one in 15, one in 100, one in a thousand", Spanos said in an interview. "They may be quite rare."
Nonetheless, the video was distributed to 15,000 doctors as part of a marketing campaign in which Purdue claimed, among other things, that the drug was less addictive and less subject to abuse than other drugs.
That wasn't true, and in 2007 The Purdue Frederick Co., an affiliate of Purdue Pharma, agreed to pay $634.5 million in penalties for misbranding the drug as part of a U.S. Justice Department investigation.
The sanctions didn't stop the pharmaceutical industry from promoting OxyContin and other narcotics for people with chronic, long-term pain -- a much larger group of potential customers than just those being treated with opioids for intense short-term pain caused by cancer and end of life pain or acute pain caused by severe injuries or surgery.
Building the market
At the time the video was produced, clinicians were often reluctant to prescribe narcotic drugs for chronic pain, fearing the risk of addiction and having little evidence of the drugs' long-term safety and effectiveness.
That changed as Purdue Pharma and other drug makers rolled out broad campaigns aimed at convincing prescribers of the efficacy and safety of their products. At the same time, professional organizations and associations that write treatment guidelines began endorsing opioids for chronic pain. Many of the people writing those guidelines had financial ties to the drug companies.
Over time, doctors began writing more and more prescriptions for opioids -- including Oxycontin, Vicodin (hydrocodone bitartrate and acetaminophen) and Percocet (acetaminophen and oxycodone) -- for more and more chronic conditions, such as back pain, fibromyalgia and arthritis.
Part of OxyContin's unique appeal was that it was a time-released version of the generic painkiller, oxycodone. Patients only had to take two pills a day, which allowed them to sleep through the night without having to get up to take more medicine.
In the 1998 video, Spanos says opioids "don't wear out," meaning patients won't need stronger doses over time.
However experts say it's common for opioid medications to lose their painkilling effect as patients develop tolerance, leading doctors to increase doses.
"Humans develop tolerance to opioids and -- pharmacologically and physiologically -- this is a well-known fact that was also well-known in the 1990s," said Beth Darnall, PhD, president of the Pain Society of Oregon and an associate professor at Oregon Health & Science University.
It worked well at first
Consider Lauren Cambra, one of the seven patients in the video. She was in her mid-40s and suffering from severe low-back pain until she went to see Spanos, who prescribed OxyContin.
"I was pain free," she said in an interview with the Journal Sentinel/MedPage Today. "I was able to get up. I could walk up a flight of stairs. I was very happy with the therapy."
Then her dose had to be doubled. Eventually it was doubled again.
She lost her job in the Dot-Com collapse and could no longer afford the $600 a month she needed for OxyContin. When she tried to do without, she spent days on the couch curled up with withdrawal symptoms.
"The next month, I knew I was going to figure out how to get the money," she said.
Instead of paying her bills or her mortgage, Cambra bought OxyContin. She lost her car and her home. She filed for bankruptcy.
Eventually, over a period of months, she weaned herself off the drug.
"I thought that if I didn't stop doing this, if I didn't get off this medicine, I'd probably end up dead," she said.
Today she is managing her back pain the way she did before she went on OxyContin. If she has a flare up, she gets a prescription for a few days of a different opioid, such as hydrocodone (Vicodin). Then she stays off the drugs completely for weeks or months.
"You could not get me to take another OxyContin," she said.
Estimating the tolerance risk
Looking back on his claim that opioids didn't wear out, Spanos said he wanted to address a 1990s stereotype that all patients would develop tolerance and need higher doses.
"I would hope that what was conveyed in the video is that there are patients in whom tolerance doesn't happen," Spanos said.
In an email, Purdue spokesman James Heins said that OxyContin labels have always included warnings about side effects and tolerance, and they're updated when new medical evidence emerges.
He noted the video was made 14 years ago and has not been shown in a decade. He also said he could not comment on what happened to the patients in the video without obtaining their permission.
Heins said statements made in the video reflected the medical consensus regarding opioids at the time.
In fact, Spanos claimed in the video that the rate of addiction among pain patients was much less than 1%.
Spanos acknowledged in a July interview that the 1% addiction figure did not come from long-term studies of chronic pain patients and that he went too far by suggesting it did. He said he regretted it if doctors got the wrong message. It has since has become clear that the percentage of patients who are addicts or will become addicted is "all over the place," Spanos said.
"Those of us who were impressed by the clear benefits for patients did not have a big enough eye on the possible unintended consequences of our enthusiasm rubbing off onto some of our colleagues,," Spanos said of opioid painkillers. "They should be reserved for people for whom the benefits justify the risks and baggage that come with the drug and the most tricky problem is that we do not know the size of the risks."
Today, the National Institute on Drug Abuse says studies among chronic pain patients have found addiction rates from 3% to 40%.
Purdue Pharma spokesman Heins said the rate of addictive disorders among chronic pain patients has not been established by prospective studies. He said the current literature suggests it ranges from less than 1% to 24%.
At least part of the discrepancy in addiction estimates has occurred because many studies exclude patients with prior substance abuse problems. However, real-world pain treatment does not.
When OxyContin was approved in 1996 there was less concern about addiction because opioids were being used mainly to treat cancer and short-term pain, said Mark Sullivan, MD, professor of psychiatry and behavioral sciences at the University of Washington in Seattle.
"They just didn't have the relevant addiction data," Sullivan said.
Addiction and pain
At least three of the seven patients in the video, including Johnny Sullivan, struggled with addiction.
Ira Pitchal, who had fibromyalgia, said in the video that OxyContin allowed him to exercise and do physical therapy, which reduced his cholesterol and returned his blood pressure to a healthy level.
A few years later, Pitchal was found dead in his Florida apartment at age 62.
The cause of death was listed as high blood pressure and cardiovascular disease, though lab tests showed the presence of two opioids in his system, nalbuphine and oxycodone.
Numerous medications were found in his kitchen cabinet and he had pills in his pocket, according to a sheriff's department report.
Pitchal had a history of alcohol and narcotic painkiller abuse, the report said. He had been released from a detox center a month before his death.
A cousin, Marilyn Frey, said Pitchal had suffered from mental health problems for years and may have doctor-shopped for pills.
"He was on gobs of medicines, probably a whole bunch at the same time that he should not have been on," she said. "So many folks who use lots of drugs perhaps would be better off with ibuprofen and some really good (psychological) therapy. I think he was one of them."
Limited research suggests that about 30% of pain clinic patients may benefit from using opioids for long-term pain, according to Ed Covington, MD, director of the Neurological Center for Pain at the Cleveland Clinic. For those best-case patients, the average pain level is reduced by an estimated 30%, he said.
Rigorous clinical trials still have not been done to measure the long-term safety and effectiveness of opioids for various kinds of chronic pain. Without such research, it is difficult to know who is likely to benefit and who is likely to be harmed.
"My biggest complaint is that they (opioids) were pushed by all the zealots in a misleading way," Covington said. "So we were given a false choice - agony without opioids, comfort with."
But when it works...
Three patients in the video say they have greatly benefited from taking OxyContin to manage their long-term pain. Two of the women had severe, debilitating conditions while the third has taken the powerful painkiller for nearly 15 years to deal with back pain.
Mary Dell, who asked that her last name not be used, said in the video that she felt normal for the first time in a decade after taking OxyContin. She had undergone spinal surgery and suffered from back pain for years.
Mary Dell, now 73 and a biotechnology researcher in North Carolina, said not much has changed for her since the video was filmed. She still takes OxyContin every day.
"I would not be able to do the work I love here if I did not take the medicine," she said. "I would be lying on the bed with a heating pad."
OxyContin also made life livable for Dorothy, a patient who asked that she be identified only by her first name.
Dorothy appeared in the video wearing a neck brace. She had been in a car accident five years earlier and had spent the time since trying to control her neck and back pain. At times, she was in so much pain she felt like a "badly injured animal" with no appetite. She remembered staring at a salad one day, unable to move to put the food in her mouth. Riding in a car was unbearable, she said.
Dorothy said Spanos monitored her medication closely and made it clear she shouldn't get narcotics from other doctors in addition to him. The drugs helped her recover from her injury. She was able to move around more and strengthen her muscles. She could keep appointments with friends and not just live hour-to-hour in her house, she said.
"As the pain got better, I got out more," she said. "Life became more predictable."
The drugs were strong, Dorothy said, and the thought of withdrawal frightened her. Her mouth was often very dry, a common side effect of opioids.
But she never felt out of control and the side effects were worth it, she said.
Dorothy said she stopped taking OxyContin in 2004 or 2005 because she got to a point where she was able to function without it.
OxyContin was "a lifesaver" for Susan, another patient in the video who asked that her last name not be used because she is still taking the medication.
Diagnosed with rheumatoid arthritis at age 25, Susan had undergone more than a dozen surgeries, including several on her hip as well as knee replacements, wrist surgery, ankle surgery, fusing of her neck and a hysterectomy.
Susan had tried for years to manage her pain. Some doctors thought she was an addict seeking pain pills, she said. The pain was so bad that she discussed suicide with her husband. Before finding Spanos and OxyContin, she was required to pick up one day's worth of medicine at a pharmacy each morning.
In the video, Susan said finding the right medicine made her life "wonderful again."
"I have found life again and it is worth living now. And I'm so grateful," she said.
Fourteen years later, Susan is still taking OxyContin. She had been taking a massive dose when the video was filmed. Now her dose is about one-tenth of that and she still deals with major pain. She can barely turn her head because her neck is fused, and her wrists are permanently crooked. Her husband Kevin has to help her stand up and she walks slowly, often grimacing in pain.
"If Susan didn't have the painkillers, she couldn't function at all," Kevin said.
For a few years after the video, Susan worked as a paid speaker for Purdue, giving talks at medical schools and to doctors.
The three patients in the video who say OxyContin has helped them are worried that additional restrictions on prescribing narcotics might prevent people like them from getting the pain relief they need.
In July, a group of nearly 40 doctors, researchers and public health officials petitioned the FDA to change the labeling on opioids in ways that would make it more difficult for drug companies to market the medications for chronic, non-cancer pain lasting longer than 90 days.
The recommended changes, if approved, might prompt Medicaid, Medicare and many private insurers to impose restrictions on paying for opioids -- hurdles that would hurt patients who benefit from the potent painkillers, according to doctors who advocate use of the drugs for long-term care.
A better approach would be to improve doctor education, especially in the area of monitoring patients for early signs of addiction, said Lynn Webster, MD, president-elect of the American Academy of Pain Medicine, in a statement.
What about side-effects?
In the video, Spanos downplayed the risk of sedation and doctors' concerns that patients on narcotics seem "sleepy and vague" and "look stoned all the time."
"Nothing could be further from the truth," he said, noting that sedation usually settles to "little or nothing within two weeks."
Numerous papers in medical journals -- published both before and after the video -- warn of the sedative effect of opioids like OxyContin.
Doctors say drowsiness can lessen in two weeks in some patients, but remain an ongoing problem for others, especially when on high doses.
Such sedation can lead to respiratory depression and even fatal overdoses.
"Enough opioids can make you sleepy to the point of dead," said Deborah Grady, MD, a professor of medicine at the University of California, San Francisco and a physician at the San Francisco VA Medical Center.
Spanos said in an interview he agrees high doses can cause sedation but those who are sedated long-term are being "over-treated."
Spanos said it remains unknown how many patients will have a "stellar response" from taking opioids.
"Back then, we all just assumed that someone, somewhere was doing rigorous studies ... and so we'd know the numbers pretty soon," he said.
"And we still don't."
The last ride
Opioids didn't just make Johnny Sullivan sleepy. They overpowered him, said his widow Mary Lou.
"He would fall asleep while we were eating," she said. "I'd hear him gasping for breath."
Early on, the drug seemed to help Sullivan, his wife said.
But then his doses had to be increased.
Sullivan had been prescribed both OxyContin and morphine. He alternated between the drugs and made sure they were never out of reach.
He kept a pouch filled with pills hidden under the seat of his pickup truck. Mary Lou said she did not know which drug he was taking at the time of the accident and a blood test was never done.
At least twice he was taken to the hospital because of an accidental overdose, Mary Lou said.
One trip to the hospital began with a strange incident at a restaurant.
"He had a hamburger, but instead of biting the hamburger he would actually be biting his hand," she said.
Mary Lou took him the emergency room and he was put in intensive care for 24 hours, but he never remembered the incident.
As time went on, the drug had more profound affects, Mary Lou said.
She had to put on his socks and shoes, shave him and wash his hair.
Sullivan's family said they were hesitant to confront him about his addiction because they knew he was in pain.
He didn't acknowledge having problems either, and still painted a positive picture in a second video that Purdue distributed in 1999.
"Never a drowsy moment around here," Johnny Sullivan said, his voice slurred and his eyes heavy.
This story was reported as a joint project of the Journal Sentinel and MedPage Today.
Steges that is why I trust a company that doesn't pump out PR's to inflate it's ego or ensnare investors. If Elite has something important to say, they will say it when the time comes. I have a feeling there is a lot of hush hush behind the scenes however once the wheels start turning and the machines are pumping out large quantities of drug's that may all change!
ELTP Technical Analysis Very Bullish
All of the technicals are aligned for a good break-out!
http://www.stockta.com/cgi-bin/analysis.pl?symb=ELTP&cobrand=&mode=stock
COUCH
I believe I was trolling the Yahoo boards one day and read a post on another board perhaps. After further reading and DD on Elite I was really impressed. It's rare that I'm drawn into an investment in this way however, the technology aspect of the two bead delivery coupled with their pipeline really floored me. I believe Elite is under the radar at the moment. Once more and more news is disseminated into the market I believe Elite will get noticed rather quickly by other pharmas, investment and financing firms.
Hello Everyone
Thought I'd join the board today. Looking forward to this week and the rest of the month. Bought in @ .14 for the long term after the patent approval.