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50% down is called luckier then he!! to buy more ELTP at rock bottom prices. I bought 65000 more shares last week. Excited for the future!!!
Camargo 505(b)(2) Blog: Abuse Deterrence Labeling
Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development
With the ongoing opioid epidemic, drug abuse, diversion, and misuse are significant concerns for the FDA. The current opioid abuse problems also present significant opportunities for companies willing to explore new formulation technologies to deter abuse.
Camargo has significant experience in opioid abuse and abuse-deterrent labeling, and is becoming a center of expertise for the industry.
Current Status
A number of abuse-deterrent formulations have been presented to the Agency to date and, in evaluating the different options for abuse-deterrent technologies, the Agency’s thinking has admittedly evolved on both data requirements to demonstrate abuse deterrence, as well as on allowable labeling claims regarding abuse deterrent technologies (as discussed by FDA officials during the recent Pfizer Advisory Committee meeting). Adding to the complication of gaining abuse deterrence labeling is the fact that the Division of Anesthetics, Analgesics, and Pain products has held an FDA Advisory Committee for each product claiming abuse deterrence properties in its proposed labeling following NDA review.
Abuse Deterrence and the FDA
Based on the 16 April 2013 notice that no new generics would be allowed to reference the old formulation of OxyContin,and the 02 July 2014 notice that the original non-abuse-deterrent OxyContin formulation was discontinued for reasons of safetyconcerns due to the abuse potential, it would appear the FDA is doing everything in its power to encourage the development of abuse-deterrent drug products to replace the non-abuse-deterrent formulations currently on the market.
Despite these efforts, groups interested in reducing the possibility of opioid abuse continue to pressure the Agency to do more faster (relevant news links: here, here, here, here, here, and here). Understanding that the removal of non-abuse-deterrent formulations from the market may be a long-term goal, it does provide a unique opportunity for drug developers with a novel formulation approach to enter a potentially lucrative market while providing a much-needed benefit to society.
In order to aid in the development and successful demonstration of abuse deterrence properties in new analgesics products, the FDA has finalized the Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.
To date, all of the abuse-deterrent formulations approved by the Agency have utilized the 505(b)(2) pathway because of the significant differences in formulation required to confer abuse-deterrent properties compared with the available non-abuse-deterrent products currently marketed.
As more abuse-deterrent formulations have been approved, demand for a pathway for generic products with abuse-deterrence properties has been increasing. The Agency responded by releasing a Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.
This new Draft Guidance focuses primarily on development of products that use the same or very similar technologies to deter abuse as a currently marketed product while maintaining therapeutic equivalence (i.e., interchangeability with the Reference Listed Drug (RLD)). While, the guidelines for testing abuse-deterrence of a generic product are now clearly laid out, the requirements add a significant burden to what is generally a fairly straightforward generics pathway.
The initial in vitro testing methods required to demonstrate similar abuse-deterrence properties for a generic product align closely with the requirements for a novel formulation, except that all testing requires comparison against the abuse-deterrent product as opposed to comparison against a non-abuse-deterrent formulation for a novel formulation. The Agency was even kind enough to define an allowable margin of non-inferiority (10%) for abuse potential testing against the RLD for the new generic formulation.
The Difference in 505(b)(2) and Generic Pathway Requirements for Abuse-Deterrent Drugs
Where the generic and 505(b)(2) pathways differ is in the in vivo requirements. Generics are only required to conduct in vivo PK studies under certain circumstances because the goal is to establish similarity to and interchangeability with the RLD for abuse-deterrent properties. Whereas, a product developed under the 505(b)(2) pathway would likely require in vivo human abuse-liability studies for each route of administration for which abuse-deterrence labeling claims are sought.
The possibility for development of generic abuse-deterrence formulations necessarily requires an innovator product to exist to compare against.
Several approved products with abuse potential still lack an alternative approved abuse-deterrent formulation, meaning that new products in those areas still require a 505(b)(2) development approach. One example area where marketed abuse-deterrent formulations are lacking is the Immediate-release (IR) opioid space.
The U.S. Centers for Disease Control (CDC) recently released its Guidelines for Prescribing Opioids for Chronic Pain in which it recommends against prescribing extended-release (ER) or long-acting (LA) opioids in preference for IR prescriptions due to the potential safety risk associated with the ER/LA products.
Obviously, it is difficult to develop a product that releases its active ingredient immediately in the stomach and still provides abuse-deterrence properties. That said, a number of formulation options are in development that may provide incremental improvements in abuse-deterrence by other common routes of abuse. A number of similar opioid and non-opioid products still have no abuse-deterrent formulations in the works, so plenty of opportunities exist for Sponsors who wish to get into this market.
Advantages of the 505(b)(2) Pathway for Abuse-Deterrent Formulations
Another area in which the 505(b)(2) pathway may be advantageous over the generics route is that specific abuse-deterrence claims may be irrelevant or unjustified based on the formulation or abuse-deterrence technology. A Sponsor pursuing the 505(b)(2) route has the flexibility to pursue only those abuse-deterrence claims for which they wish to make a claim in their approved labeling.
To use the above example of an IR oxycodone product, if the product is intended to release oxycodone immediately when administered by the oral route, then oral abuse-deterrence claims would be irrelevant because an abuser could intentionally administer enough of the product orally to produce a euphoric “high” from the drug. In this case, it would be reasonable to pursue intranasal and possibly intravenous (depending on the abuse deterrence mechanism), but not oral abuse deterrence claims.
While some mechanisms may deter even oral abuse by so-called programmable release formulations, it is important to remember that the product must still accomplish its intended role of providing analgesia to patients who require significant pain relief. The 505(b)(2) pathway provides the flexibility to pursue only those claims that are reasonable and apply to the abuse-deterrent formulation.
While navigating the development requirements for an abuse-deterrent formulation are clearer now than ever before, it is also clear that this is a constantly evolving field that requires both experience and creative, agile thinking to achieve success.
The efficiencies and flexibility gained by the 505(b)(2) development pathway extend to the demonstration of abuse-deterrence properties for drugs with abuse potential. Even compared against generics, the 505(b)(2) pathway provides an efficient and flexible development path for those looking to enter this unique market.
With a multidisciplinary staff and extensive 505(b)(2) experience, Camargo offers the expertise needed to navigate the complex regulatory matters involved with developing abuse-deterrent drugs via the 505(b)(2) pathway. Contact us to learn more.
Author: Eric Kendig, Ph.D., Senior Scientific and Regulatory Manager, Camargo Pharmaceutical Services
http://www.insiderfinancial.com/tag/elite-pharmaceuticals/
Insider Financial
Here’s What Really Happened To Elite Pharmaceuticals Inc (OTCMKTS:ELTP)
By Chris Sandburg / in Biotech & Pharma, Momentum Stocks, Stocks / on Tuesday, 19 Jul 2016 01:32 PM / 0 Comment / 638 views
Elite Pharmaceuticals Inc (OTCMKTS:ELTP) just picked up a complete response letter (CRL) from the FDA relating to its lead abuse deterrent opioid candidate, and is taking a beating on the open market as a result. Heading in to the Tuesday morning open in the US, the company is down 40% on its July highs. On Monday, the company took to a conference call to explain the CRL, and on the call suggested there’s still a chance of approval for its candidate, SequestOx. Is this just spin, or can Elite recover? Let’s try and figure it out.
First, a quick introduction to SequestOx. As mentioned, its an abuse deterrent opioid treatment designed and developed with Elite’s abuse deterrent platform. Basically, it’s a pill with two components – an opioid agonist and an opioid. If taken correctly, the opioid agonist passes through the body with no effect. If crushed or dissolved, however, the agonist binds to the same receptors as would the opioid, and essentially nullifies the impact of the latter. Some good news first – the CRL didn’t mention any issues with the tech, so we know the agency is happy with the abuse deterrent element of the drug. That’s pretty big news in itself.
So what happened? Well, in pharmacology there are two measurements called Cmax and Tmax that relate to how the drug moves through the body. The first relates to peak concentration (so basically, how strong the drug is) and the second to how long it takes for the drug to reach this peak concentration. When taken with fatty food, the Cmax of SequestOx is the same as when taken with no food or a light meal. However, Tmax is higher. This means it takes longer to hit peak concentration. This means a patient could take the drug, expect a certain level of relief, but not get it because of the higher Tmax. In response, the patient could take another pill, and theoretically overdose. Elite knew this when it submitted the NDA (it had conducted trials that demonstrated this effect) but it believed that it could resolve the issue with labeling. Specifically, a note on the packaging saying don’t take this with fatty food, that sort of thing. However, because the drug is designed for on demand pain relief, the FDA isn’t happy with this solution. If the drug was designed for chronic pain, this isn’t an issue, because a patient can plan to take the drug before eating. Since it’s a responsive administration, however, they cannot plan.
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So what’s the outcome? Elite believes that if it can demonstrate no difference in Tmax when sprinkled on a fatty meal, then the FDA will accept that as a resolution and approve the drug with a label explaining this dosing method. It’s going to the FDA over the coming weeks with this proposal, and if the agency agrees to the resolution, we should see a trial kick off this quarter. Then, all eyes will be on the topline and – specifically – the Tmax data.
All this assumes, of course, that the agency accepts the sprinkling as a resolution. This author believes that doesn’t really overcome the issue. Why? Say a patient eats a meal, then gets pain 30 minutes later. Chances are the Tmax is still going to be affected by said meal, but the patient has missed the chance for sprinkled administration. Anyway, we’ll see what the agency says come meet day.
If it accepts Elite’s proposal, this could be a really great opportunity to get into the stock at a discount. As mentioned, the CRL validates the tech underpinning the drug, and there is a raft of other biosimilars in its pipeline poised for submission.
Keep in mind that markets sold off on the company before the CRL was explained – a great example of inefficiency. Inefficiency can serve up opportunities in this sort of situation.
Definitely one to keep an eye on.
FDA employees bought a lot shares today.
This could be a 20 million volume day!! Awesome!
You are crazy if you sell at the open.
Good day to buy
I will be the scapegoat for this test. I will get a cheeseburger and fries and we will get this test rolling!!! I see no reason to get worried here!! If the market drops whatever. Like couch said, "nobody going to stop us." Good update Nasrat!!
Things that make you go mmmm!!!
http://time.com/4036811/fda-new-head-robert-califf/
Dr. Robert Califf has been nominated by Obama for Commissioner of the FDA
President Obama nominated Dr. Robert Califf as the new head of the U.S. Food and Drug Administration (FDA) this week. But who is he?
Earlier this year, Califf was named the FDA’s deputy commissioner for medical products and tobacco (the No. 2 role at the agency). Califf, a cardiologist, is known as a prolific researcher, though he has faced criticism for having financial ties to pharmaceutical companies.
Califf came to the FDA from Duke University, where he was the vice chancellor of clinical and translational research. He was also the director of the Duke Translational Medicine Institute (DTMI) and a professor. He received his own degrees from the University.
When Dr. Califf, a cardiologist, first stepped into his FDA position in March 2015, the agency noted that he was recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications. “During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research,” the FDA said at the time. “He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care.”
Dr. Califf is not expected to be controversial in the Senate, which will vote on his appointment, the Wall Street Journal reports.
Not everyone is pleased by the appointment, however. In a statement, Dr. Michael Carome, director of the Public Citizen’s Health Research Group, said the Senate should reject the nomination due to Califf’s ties to pharmaceutical companies and medical device manufacturers (something TIME reported on in February): “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” Carome said.
Califf did not immediately respond to a request for comment on Wednesday.
In an interview with TIME earlier this year, Califf said less than half of his yearly salary comes from research funds from the pharmaceutical industry. Califf told TIME in the interview that he was divesting his holdings in two privately-held pharmaceutical companies.
“The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf told TIME. He added that it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”
As the new FDA commissioner, Califf may have a lot on his plate, according to the Washington Post. For example, new legislation known as the 21st Century Cures Act is making its way through the approval process and could change the pace at which the FDA approves drugs and devices.
Califf was one of several nominations Obama made on Tuesday. “I am confident that these experienced and hardworking individuals will help us tackle the important challenges facing America, and I am grateful for their service,” the President said in a statement. “I look forward to working with them.”
Depending on the outcome of the CC tomorrow. This could be the smartest thing management could of done. PR after hours on Friday and address everything before the bell on Monday. Hope everything works out. Holding strong.
The MM's could really hurt some investors here. Drop the PPS to .10 Monday morning after everyone sells off jump it back up to .33 at the end of the day. Investors will have some decision making on Monday.
Kempharm had an PDUFA date for Apadaz on June 9 a Thursday and didn't PR the results till end of the trading day on Monday the 13. If ELTP doesn't announce today so be it. The beer will still taste just as good on Monday. GL
Probably halt trading 10 minutes before news hits last hour of trading.
Agreed. I am out. See you tomorrow!
.39 open!
If the FDA approves ELI-200, they will likely approve the other painkillers they file also. Easy money for the next couple of years.
I would say no ADCOM for us either.
http://www.insidermonkey.com/blog/is-pain-therapeutics-inc-ptie-and-remoxys-long-and-winding-road-nearing-an-end-463031/
Pain Therapeutics, Inc. (NASDAQ:PTIE) just got word from the FDA that the advisory committee meeting scheduled for August 5 to discuss its lead development candidate, Remoxy, is no longer needed. While it’s a little bit presumptive to suggest that this is good news for the company (and the drug’s chances of approval come PDUFA), so long as the NDA is still under active review – which it is – then it’s reasonable to conclude positive inference. With this in mind, and ahead of the PDUFA date, here’s a look at the drug in question and a discussion as to what an approval might mean for the company and its shareholders going forward.
IR) immediate release is more prescribed by doctors then extended release opioids. Great news for Elite!! This will be life changing and I am excited to be here at the start of something so great. Two weeks baby!!! Elite the 1st IR ADF opioid ever!!!
Opioids with FDA-Approved Labeling Describing Abuse-Deterrent Properties
FDA has approved these extended-release/long-acting (ER/LA) opioids with labeling describing abuse-deterrent properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:
OxyContin
Targiniq ER
Embeda
Hysingla ER
MorphaBond
Xtampza ER
There are currently NO immediate-release or generic opioids with FDA-approved abuse-deterrent labeling.
How does the FDA decide what drugs are considered abuse-deterrent?
To meet the FDA’s standards, it is essential that every opioid with labeling describing its abuse-deterrent properties be grounded in science and supported by evidence. Any claims regarding abuse-deterrent properties must be truthful and not misleading based on a product’s labeling, and supported by sound science taking into consideration the totality of the data for the particular drug. Absent sufficient science, there can be no claim of abuse deterrence. Permitting insufficiently proven claims does not serve the public health.
There are two primary categories of opioid medications: immediate release (IR) , which are the most often prescribed type of opioid, and extended-release /long-acting (ER/LA). The labeling for both have recently received multiple updates to more effectively communicate to prescribers the serious risks associated with these drugs
http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM484743.pdf
Fact Sheet – FDA Opioids Action Plan
The FDA is deeply concerned about the growing epidemic of opioid abuse, dependence and overdose in the United States. In response to this crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. As part of this plan, the agency is committing to work more closely with its advisory committees before making critical product and labeling decisions; enhancing safety labeling; requiring new data; and seeking to improve treatment of both addiction and pain. At the same time, the FDA will fundamentally re-examine the risk-benefit paradigm for opioids and ensure that the agency considers the wider public health effects. The FDA is committed to taking all of these steps transparently and in close cooperation with its sister agencies and stakeholders.
The FDA’s actions include:
Expand use of advisory committees. Starting today, the FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. And the Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved. The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when they raise novel issues. Outcome: Review and advice from external experts with opportunity for public input before approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling.
Develop warnings and safety information for immediate-release (IR) opioid labeling. The FDA is developing changes to IR opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling update that occurred in 2013. Outcome: Better information for doctors about the risks and how to prescribe safely.
Strengthen postmarket requirements. Because the evidence base to guide the use of opioid medications, particularly in the setting of long-term use, is substantially lacking, the FDA is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Outcome: Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements. Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.
Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs. Outcome: Spur innovation and generic ADF product development.
Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone. The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments. Outcome: Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academies of Sciences, Engineering, and Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them. These reports will be publicly available. Outcome: Formal incorporation of the broader public health impact of opioid abuse in approval decisions.
That was a sign from Mr. Nasrat saying that we will be approved and are moving forward!!! Good times ahead!! IMO!!!
It will be at .33 by the end of today!!
This is awesome!!! BUY BUY BUY!!!!!
Good looking hammer candle above the 50sma on the daily.
This is the best thing that could of happened. Usually it goes up till the news hits then drops like a rock. I believe it is still getting ready for approval. Today was a good indicator to buy! Go long!!
Thanks couch!
How Pharma Copes with the Pain of Developing Abuse-Deterrent Opioids
https://citeline.com/wp-content/uploads/2015/02/Jan-2015_Abuse-Deterrent-Opioids_HeidiChen.pdf
With the wide availability of generic opioid analgesics, such as oxycodone and hydromorphone, the abuse of prescription opioids has become a major public health problem in the US. Consequently, in January 2013, the FDA released draft guidance for drug makers that mandates inclusion of abuse- deterrent technology for new opioid products. Data from Pharmaprojects and Trialtrove were analyzed to explore the current development for opioid analgesics with abuse-deter- rent technology in order to gain insight into the front runners of this competitive area, their characteristics, and the top sponsors on the verge of becoming market leaders.
One of the most common approaches in abuse-deterrent technology is the development of new formulations of extended-release opioids, or tamper resistant properties that render the drugs difficult to crush, grind, and dissolve for injection or nasal insufflation by potential abusers. The reformulation approach for approved opioids, with their proven efficacy and acceptable safety profiles, is an attractive develop- ment pathway that requires primarily safety and bioequivalence studies and leads to an abbreviated clinical program.
Pharmaprojects profiles for the current reformulations applied to the opioid compounds, and their abuse-deterrent technologies, are captured in Figure 1. The majority of reformulations involve modified-release of the opioid over time (immediate-release, <24 hour-release) or fixed-dose combinations that render the drug more resistant to crushing or abuse. Other abuse deterrent technologies, such as transdermal patch and transmucosal delivery technologies, are a small niche that may offer an alternative to oral or injectable routes of administration without compromising the physical integrity of the compound.
Besides rendering the opioid resistant to physical manipulations, reformulations can be designed to alter how the drug binds to opioid receptors, thereby, reducing the potential euphoric effect and discouraging abuse behavior. One example is the use of naltrexone in fixed-dose combination with an opioid. Naltrexone acts as an opioid receptor antagonist by blocking opioid receptors in the brain and produces a “withdrawal” rather than a euphoric effect. The specific details of how drug developers incorporate abuse-deterrent technology are usually considered proprietary, but may be disclosed more widely once these new drugs reach the market.
Trialtrove data profiles the clinical trials of the top 10 sponsors for abuse-deterrent opioids, illustrating that nearly 60% of the 109 trials are Phase I studies because most of these drugs are reformulations of marketed opioids. These programs require fewer clinical trials and focus primarily on bioequivalence and the effectiveness of tamper-resistant technologies. Purdue Pharma, whose Oxycontin was the market leader prior to generics reaching the market, is the top sponsor by number of sponsored trials. Aside from Pfizer and Johnson & Johnson, the majority of the sponsors are considered “boutique” firms with a vested interest or specialty in pain therapeutics. These smaller pharmaceutical companies have a focus on proprietary controlled-release and tamper proofing technologies, which are combined with the marketed opioids, to facilitate generation of new pain medications.
The table summarizes the notable clinical-stage candidates of abuse-deterrent opioids, many of which are sponsored by the top 10 companies. Clearly there is a healthy pipeline of both pre-registration and Phase III programs.
After the FDA published its guidance on abuse-deterrent opioids in January 2013, the October 2013 approval of Zohydro ER, a 12hr controlled-release formulation of the highly potent opioid hydrocodone without anti-abuse protection, caused heated debates, as critics voiced concerns that this approval puts patients at unnecessary risk. The FDA stood by its decision that the requirement of abuse-deterrent properties for all new opioid drugs was not feasible at the time. Today, Zogenix continues to fill their pipeline with new Zohydro ER candidates. Their hydrocodone bitartrate (extended-release) is a pre-reg- istration stage compound utilizing Alkermes’ Spheroidal Oral Drug Absorption System as the deterrent technology, and a second hydrocodone bitartrate (extended-release) formulated with Altus’ proprietary Intellitab drug delivery platform is in Phase I development. If approved, Zogenix intends to transition the currently marketed Zohydro ER to the modified formulation of Zohydro ER that has been designed to have abuse deterrent properties. Zogenix’s strategy of releasing Zohydro ER first, followed by the “upgraded” versions containing abuse-deterrent properties, may give Zogenix an advantage by extending patent protection on the drug.
In addition, Purdue, who completed pivotal trials for Hysingla ER in early 2014 with positive results, was granted priority review by the FDA for this compound. Since acquiring Cephalon’s hydrocodone bitartrate, Teva’s CEP-33237 has shown a consistent safety profile and efficacy in patients with chronic low back pain. Pfizer’s naltrexone + oxycodone FDC (AL-02) completed its pivotal phase III trials in 2014 and is ready to advance towards NDA submission. Elite Pharmaceuticals has a rich pipeline of abuse-deterrent opioids, most of which are in Phase III development. In early December 2014, Elite reported successful results from a pivotal study of its twice- daily naltrexone+oxycodone FDC. Elite Pharmaceuticals plans to submit a NDA filing, which places it in direct competition with Pfizer’s FDC candidate.
Since the FDA released its draft guideline for development of abuse-deterrent opioids in January 2013, considerable industry development produced a first wave of new therapeutics to reach the registration stage. The relative ease with which this approved class of effective pain drugs can be reformulated, and the huge unmet need of reducing the risk of opioid abuse, has contributed to this robust wave of development by many sponsors. The FDA has since met with industry sponsors to discuss new approaches to pain management, but development of novel classes of pain drugs remains at an early stage. In recent FDA news, CDER disclosed its 2015 priorities, including issuing final guidance on abuse-deterrent opioid formulations as one of its front burner priorities. As we await the much anticipated final guidance in 2015, Citeline will be looking closely at how the FDA will shape the opioid market. Hopefully, these steps will enable access to effective pain medications while reducing the risk of prescription drug abuses that have now reached near epidemic proportions.
How Pharma Copes with the Pain of Developing Abuse-Deterrent Opioids
https://citeline.com/wp-content/uploads/2015/02/Jan-2015_Abuse-Deterrent-Opioids_HeidiChen.pdf
Ever so often I type in different criteria in a search engine then just the norm. Seeing if I can find any rare information like the pieces I found today. Really made me excited for next month. Elite investors need to realize this isn't just one drug possibly getting approved on July 14.
This is 14 drugs!!!!! Yeahhhhh!!!
The world is excited about Elite Pharmaceuticals!
Rationale for acquisition of Epic Pharma by PuraCap?
Humanwell Healthcare and PuraCap to acquire Epic Pharma
The news last week that China-based Humanwell Healthcare Group and PuraCap Pharmaceutical have entered into a definitive agreement to acquire 100% of privately-held US generic drugs marker Epic Pharma for $550 million (The Pharma Letter April 8), seems to have a sub-text: an unidentified product license asset.
In June 2015, Elite Pharmaceuticals (OTC: ELTP) licensed SequestOX (naltrexone and oxycodone hydrochloride), then known only as ELI-200, to Epic Pharma. This was Elite’s lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Under the terms of the deal, Epic was due to pay Elite non-refundable milestone payments totaling $15 million and a royalty based on net product sales. The term of the license is five years and the license is renewable upon mutual agreement at the end of the initial term.
According to a long-term investor in Elite and other pharmaceutical companies working to help solve the opioid abuse epidemic who contacted TPL, “PuraCap wants in on the opioid market, and Elite's proprietary technology and its licensing deal with Epic was their way of gaining that access.”
He noted that, in March this year, the US Food and Drug Administration had fast-tracked the review for SequestOX and a decision is to be rendered by July 14, target action date under the Prescription Drug User Fee Act (PDUFA). The FDA granted priority review of the drug.
At that time, Elite’s president and chief executive Nasrat Hakim said: “The FDA’s decision to grant Priority Review to the SequestOX submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse.”
“The purchase of Epic gives Humanwell and PuraCap a front row seat to SequestOX being approved by the FDA in July. Great acquisition on their part,” the investor told TPL.
No it is a opioid addiction treatment drug.
ELTP is running in the same situation. Approval date is scheduled for July 14. I see a run up here shortly.
TTNP Titan Pharma had an FDA target action date for May 27 for their NDA Phobuphine. The FDA approved it on the 26. ELTP will probably go down to the wire also.
It would be a great day to bounce off the 200ma, close the gap and start are journey North before we hit our target action date of July14!!
That is my bid. Time to load up.
I agree.
Stockpalooza is pumping ELTP today.
More like baking or burnt as crisp!! Maybe toast!! Burnt toast that is!! Trash stock.