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.
Eight months ago, huh? Hmmmmm.
Oh by the way, that was 8 months ago, I am sure FDA is in full crisis mode LOL
The drugmaker was slated to appear before the FDA's panel of analgesic experts on July 7 to go over whether its new formulation of the oxycodone drug is successfully deterring abuse. But Purdue has since backed out of that meeting and canceled its supplemental application altogether, saying it wants more time to review its data.
"Given the complexity of epidemiological research and the unprecedented nature of this exercise, we've made the decision to complete additional analyses, which we now believe are essential to building the most compelling body of epidemiological evidence," Richard Fanelli, Purdue's head of regulatory affairs, said in a statement.
Fun With Pharmacokinetics: OxyContin In Trouble?
Here's a gem from Collegium's Xtampza ER advisory committee material:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM461640.pdf
Look at the dotted orange line which mimics the solid red line. This is Collegium showing the FDA that crushed (read: chewed) OxyContin is just like crushed IMMEDIATE RELEASE generic oxyIR. This is important. FDA says if there is an ADF that does something yours does not, then you could be pulled. Collegium shows their Xtampza is crush-proof while OxyContin dose dumps with physical manipulation.
Pfizer's ALO-2 12 hr oxy is an antagonist ADF and will have flat-line drug liking curve similar to what we see with ELI-200. Elite's 12 hr oxy ELI-201 would likely have similar flat line drug liking. IPCI claims Rexista is months away- I assume it works. How many 12 hour oxy formulas that are TRULY crush-resistant will hit the market before the FDA pulls dose-dumping OxyContin?
By the way, notice how when Xtampza is crushed (blue lines), the oxy is released at the regular rate (controlled over 12 hours), as opposed to OxyContin, which appears to release all the oxy immediately. But when both ALO-2 and ELI-201 are crushed, naltrexone is released. Therefore, ALO-2 and ELI-201 will look much better on the drug liking curve than both OxyContin AND Xtampza (and, really, most if not all the hard shell and gummy ADF's).
Dear WeeZuhl,
Some of our regular readers send questions to WeeZuhl. Here’s a recent arrival to the inbox.
Dear WeeZuhl,
I have a question that I have seen them arguing about on the Elite Facebook page. The question is: If Elite’s drugs are not crushed does it or does it not behave like any other opioid when taken as directed?
If a user takes more than directed without crushing it, will they not get high and possibly overdose?
Please explain this with a post to the board.
Thank you,
Afraid On Facebook
q12h as causation for increased dependence and eventual addiction
KMPH's market value has decreased by over $100mm on this news. Based on this valuation decrease it must be concluded that KMPH investors anticipated and priced in an adf label before yesterday's news.
These facts suggest that an ADF label has been priced into the market for ELTP, and actual approval of that ADF label may not result in the huge increases in valuation some are predicting, and failure to obtain the same could cause a decrease similar to that experienced today by KMPH.
It's not labeled, but...
Referencing the ELI200 chart in WeeZhul's post:
What is the timeframe on the x-axis for ELI200 snorting trials?
FDA has spoken, Products that use Naltrexone to prevent tampering does NOT DETER ABUSE, and will not be allowed Abuse Deterrent labeling.
Nobody is fooled, doc
Like all true and faithful longs, doc loves his SequestOx!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112385298
Could be a nice product for someone but hardly the billions and billions we keep hearing about
In contrast, this is what the drug liking curve looks like for what will be the first-ever immediate-release opioid to receive Category II ADF label.
Kempharm fails to acquire ADF label.
Here's why:
Kempharm was applying for a Category II ADF label based on the above PK graphs of KP201. Intranasal KP201 is orange line and hydrocodone is blue line.
https://www.sec.gov/Archives/edgar/data/1434647/000156459015008097/kmph-ex991_6.htm
Data from the KP201.A03 intranasal human abuse liability trial, which was designed to compare the amount of hydrocodone released from KP201 and from hydrocodone bitartrate (HB) (both without APAP) after insufflation, demonstrated a statistically significant reduction in Cmax, a delay in Tmax, and a significant decrease in total exposure to hydrocodone especially at early time points typically associated with increased drug liking, abuse and safety. Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB, with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB.
This is what I think will happen.
Or maybe the problem gets so bad they re-evaluate ADFs cost versus lives. Their "review of the latest scientific evidence"
may need another review.
2009 called. They want their warrants complaint back.
There have been no new warrants since 2009. All of the warrants were via 2009 Epic Strategic Alliance, which was lifeline funding. It saved the company, but it is one of the negative factors that drove this stock down to single digits and allowed so many of us buy substantial portions of the company. This is excellent DD- just unfortunate you did not come upon it five years sooner. Now the warrants are all gone. Epic distributed the last of theirs in 2015, and most of those went to directors with reporting responsibilities. There are a few million stragglers out there, including some like these that expire next month. Others expire later 2016 and some 2018.
As these stragglers come home to roost, it provides R&D $$ for Elite. And of course, the other thing that is coming home to roost from the 2009 Epic Alliance is 15% $$ of their recently-approved oxycodone ANDA. And we get that just for looking pretty, which we do.
Today's Form 4 by Carter Ward is interesting. I do not recall ever seeing him report warrants. His filings are usually stock & options. Dianne Will told me via telephone last year that she thought Carter was also a member of Epic, but I had never seen any evidence of it until today.
I think the point is pretty clear.
Nice read
Not much else than personal opinions that make no point whatsoever last weeks
Seems like only long term investors are able to post facts , backed up with links
Canada: Abuse Deterrent Opioids Too Expensive
April 12, 2016
By Pat Anson, Editor
At a time when the U.S. Food and Drug Administration is actively promoting the development of more opioid pain medication with abuse deterrent formulas (ADFs), Canada is saying the drugs are too expensive and will have “little to no effect” in the fight against opioid abuse and addiction.
Health Canada last week rejected a proposed regulation that would require all medications containing the painkiller oxycodone to have tamper resistant properties. ADFs generally make it harder for drug abusers to crush or liquefy opioids so they can be snorted or injected.
“(After) a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact,” Health Canada said in a statement.
Trying to prevent opioid abuse is like the world’s sorriest game of Whack-A-Mole. When abuse-deterrent OxyContin was introduced, heroin overdoses increased by 26%.
(http://archinte.jamanetwork.com/article.aspx?articleid=2276923).
The ADF’s, including ELTP’s 2 bead pharma-based ADF, will prevent abuse where the pills are crushed for snorting or injection. The majority of abusers will not be affected by these ADF’s because they swallow whole pills, but the hardcore IV users will move on to something else. Maybe to heroin, more likely black-market fentanyl these days.
https://www.bostonglobe.com/metro/2016/05/02/fentanyl-involved-more-than-half-overdose-deaths-state-reports/ALpo8q8VRHxa27Tzm6YYvL/story.html
More than half the people who died last year from opioid overdoses had fentanyl in their bloodstreams, according to data released Monday by the state Department of Public Health. The … synthetic opioid -- more powerful than morphine or heroin -- may be playing a major role in the overdose epidemic. Dealers are believed to be lacing heroin with fentanyl, making it even more deadly.
Chinese labs have created a new form of fentanyl, a powerful opioid, called furanyl fentanyl. This new iteration of the drug skirts Chinese export laws and isn’t on the US’s banned substances list—which means it’s technically legal to sell on the streets, with the same affects as the real the original drug.
“Laboratories are automatically tweaking the formula to come up with the next analog,” DEA spokesman Russell Baer Baer, told STAT. “We will seek to put furanyl fentanyl on the list (of controlled substances), and then they will tweak one molecule, and in two months we will be discussing that one. It is a challenging process for us.”
Labeled W-18, the synthetic opioid was the most powerful in a series of about 30 compounds concocted at the University of Alberta. But no pharmaceutical company would pick it up, so on a shelf the recipe sat, the research chronicled in medical journals but never put to use. The compound was largely forgotten.
Then a Chinese chemist found it, and in labs halfway around the world started developing the drug for consumers in search of a cheap and legal high — one experts say is 100 times more potent than fentanyl and 10,000 stronger than morphine.
REPOST: My favorite R&R slide.
Shows Mean Drug Liking on Visiual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) is actually *disliked* at the outset- see how the blue line falls below the placebos (red & yellow). For some reason, drug abusers disliked snorting it, as opposed to feeling neutral, like snorting the placebo. And ELI-200 never bumps above the placebo line, indicating the naltrexone effect is long-lasting. (I'm looking at you, alleged-ADF Targiniq, with your short half-life naloxone instead of longer half-life naltrexone.) A great data slide. Thanks Nasrat!
Solve addiction?
No matter how successful abuse deferent pain killers become, they will not solve the problem for those already addicted to opioids. Chemical dependency had already happened in these individuals.
I care about SequestOx ER 12 & 24 and SequestMorph and SequestHC.
...I’ve said this before, I have more than a dozen ideas for our stock that are ready to go into clinical trials and into the market. We don’t have to mind or to execute all of them. So we decide which are the cream of the crop, the top two, three, or four, and focus on these, keeping in mind how much they’re going to cost..
You do not sell a billion dollar technology for one product’s price.
About 90% of opioid prescribing is for some 175 immediate-release (IR) products, including more than 100 generics.
The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
Exactly right.
As you are aware, and shorts ignore, is the fact that the stream of news prior to ELI-200 approval has a material impact on the pipeline going forward.
Great Question
Won't ELTP have to wait for Pfizer's patent to expire before a generic is allowed?
The 505(b)(2) strategy has been underutilized in the 16 years since it was legislated. One reason might
be the recent controversy over its constitutionality, as Pfizer and other large pharmaceutical companies
have petitioned against approvals of 505(b)(2) NDAs. They argue that it is unconstitutional for the FDA
to rely on the innovator’s proprietary data and that this application violates Fifth Amendment rights. No
court decision has yet been rendered on the constitutionality, but in October, the FDA released a
statement reaffirming their interpretation of Section 505(b)(2) and rejecting many petitioners’ complaints
ELI-201 Reference Drug Moving Forward
Pfizer is moving forward with pediatric studies for ALO-2. This will allow for additional market exclusivity upon completion. They have a similar study for Embeda, which has been an ongoing trial since 2014. This ALO-2 study was added in January and updated in the past 2 weeks to show recruitment.
This is important for ELI-201, since Nasrat has indicated that he may use the 505b2 NDA pathway with Pfizer's ALO-2 oxy/naltrexone 12 hour drug as a reference. We need ALO-2 approval before that can happen. Some have suggested that FDA's delay in approval for ALO-2 spells trouble, and maybe so. But we're rooting strongly for Pfizer on this, not just because ALO-2 is 505b2-bait but also because Pfizer's marketing department is our bestest friend forever in the category of pharmacological-based ADF's.
I strongly doubt Pfizer would be moving forward with these ALO-2 studies at this time if they were not 100% confident in ALO-2.
Go Pfizer! (Ugh. I feel dirty now.)
You make an important point here, namtae
Quote:
Licensing Fees 403,999
To be clear, for the corresponding period in 2014, $207,645 were recorded for licensing fees
Like I said...
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=HTWEe33gpUeB8-9&ID=10853601
Licensing, Manufacturing and Development Agreements
Sales and Distribution Licensing Agreement with Epic for Abuse-Deterrent ELI-200
On June 4, 2015, Elite Pharmaceuticals Inc. and its wholly-owned subsidiary Elite Laboratories, Inc. (collectively, “Elite”) executed an exclusive
License Agreement (the “Agreement”) with Epic Pharma LLC. (“Epic”), to market and sell in the United States, ELI-200, an undisclosed opioid
with sequestered naltrexone capsules, owned by Elite. Epic will have the exclusive right to market ELI-200 and its various dosage forms as listed
in Schedule A of the Agreement (the “Products”). Epic is responsible for all regulatory and pharmacovigilance matters related to the products.
Pursuant to the Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of net sales
of the Products as defined in the Agreement by Epic. Elite will manufacture the product for sale by Epic on a cost plus basis and both parties
agree to execute a separate Manufacturing and Supply Agreement. The license fee is payable quarterly for the term of the Agreement. Epic shall
pay to Elite certain milestone payments as defined by the Agreement. The first milestone payment was due and was received upon signing the
agreement. Subsequent milestone payments are due upon the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug
Administration (“FDA”) for the Products and upon receipt of the approval letter for the NDA from the FDA. The term of the License Agreement
is five years and may be extended for an additional five years upon mutual agreement of the parties. Elite can terminate the Agreement on 90
days’ written notice in the Event that Epic does not pay to Elite certain minimum annual license fees over the initial five year term of the
Agreement. Either party may terminate this Agreement upon a material breach and failure to cure that breach by the other party within a
specified period.
· Phendimetrazine 35mg
· Isradipine 2.5mg and Isradipine 5mg
· Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg
6
Manufacturing and License Agreement with Epic Pharma LLC
On October 2, 2013, Elite executed the Epic Pharma Manufacturing and License Agreement. This agreement granted Epic Pharma certain rights
to manufacture, market and sell in the United States and Puerto Rico the 12 approved ANDAs acquired by Elite pursuant to the Mikah Purchase
Agreement. Of the 12 approved ANDAs, Epic Pharma will have the exclusive right to market six products as listed in Schedule A of the Epic
Pharma Manufacturing and License Agreement, and a non-exclusive right to market six products as listed in Schedule D of the Epic Pharma
Manufacturing and License Agreement. Epic Pharma is responsible for all regulatory and pharmacovigilance matters related to the products and
for all costs related to the site transfer for all products. Pursuant to the Epic Pharma Manufacturing and License Agreement, Elite will receive a
license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined in the Epic Pharma
Manufacturing and License Agreement, earned by Epic Pharma a result of sales of the products. The manufacturing cost used for the calculation
of the license fee is a predetermined amount per unit plus the cost of the drug substance (API) and the sales cost for the calculation is
predetermined based on net sales. If Elite manufactures any product for sale by Epic Pharma, then Epic Pharma shall pay to Elite that same
predetermined manufacturing cost per unit plus the cost of the API. The license fee is payable monthly for the term of the Epic Pharma
Manufacturing and License Agreement. Epic Pharma shall pay to Elite certain milestone payments as defined by the Epic Pharma Manufacturing
and License Agreement. To date, milestones totaling $1,000,000 have been earned and received in relation to the signing of the Epic Pharma
Manufacturing and License Agreement and the filing and approval by the FDA of supplements relating to the transfer of manufacturing site for
Isradipine 2.5mg and Isradipine 5mg. The term of the Epic Pharma Manufacturing and License Agreement is five years and may be extended for
an additional five years upon mutual agreement of the parties. Twelve months following the launch of a product covered by the Epic Pharma
Manufacturing and License Agreement, Elite may terminate the marketing rights for any product if the license fee paid by Epic Pharma falls
below a designated amount for a six month period of that product. Elite may also terminate the exclusive marketing rights if Epic Pharma is
unable to meet the annual unit volume forecast for a designated product group for any year, subject to the ability of Epic Pharma, during the
succeeding six month period, to achieve at least one-half of the prior year’s minimum annual unit forecast. The Epic Pharma Manufacturing and
License Agreement may be terminated by mutual agreement of Elite and Epic Pharma, as a result of a breach by either party that is not cured
within 60 days notice of the breach, or by Elite as a result of Epic Pharma becoming a party to a bankruptcy, reorganization or other insolvency
proceeding that continues for a period of 30 days or more.
Misinformation.
Correct info here:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122229297
DD is hard.
DD is hard.
Your mistake here is to confuse the 2013 Epic Agreement on generic drugs with the 2015 Epic Agreement on ELI-200. The $403,999 is cash received for the 2013 generic drugs, whereas the $5,000,000 ELI-200 milestone payment is on the very next line down of the original 10Q. If one is really interested in proper DD on this subject, one could refer to the discussion in the same 10Q of the "Milestone Method" of accounting for this $5,000,000 payment, which was subsequently re-stated following comment from SEC to realize the $5,000,000 over the entire term of the agreement. You can find the links for yourself, but the most relevant passage for those interested in accurate information on the ELI-200 milestone can be found here:
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=HTWEe33gpUeB8-9&ID=11159374
Please note that the $5 million payment received from Epic is non-refundable. Recognition of this payment as revenue on its date of receipt or over
the exclusivity period (currently coinciding with the five year term of the 2015 Epic License Agreement), does not alter the fact that the Company
is not required to return any portion of this $5 million received from Epic, and the Company can, and has, used these funds to advance the
Company’s business objectives. Accordingly, management believes that this correction of accounting error has no material effect on the
Company’s operations or future prospects.
Epic Licensing fee - heres some info!
In the 10Q ending June 30, 2015, which encompasses.. the new Epic licensing agreement dated June 4th, LICENSING REVENUES for the quarter totaled the following:
Quote:
-------------------------------------------------------
Licensing Fees 403,999
-------------------------------------------------------
Therefore, anywhere from $0 - $403,999 were supposed to be paid to ELTP upon signing the agreement, which occurred June 4th.
This is the apparent upfront cost to license the $multiBIllion Eli200.
To be clear, for the corresponding period in 2014, $207,645 were recorded for licensing fees
I'd be a little concerned if I were you
I’ve been in the mud with this pig for a long time now, and let me tell you, she stinks pretty good these days compared to when I went head-deep in the slop. But now that my smelly pig is four times the size she used to be, I’ve got all sorts of folks lined up to tell me how much my pig stinks.
I love the way my fat pig stinks. If she didn’t smell so bad, I never could have afforded her. I figure she’ll be ready for slaughter ~2018, until then you’ll have to find your own smelly pig because I’m not selling mine.
Long & Strong ELTP,
W.
Final Phase II Results: AE37 improves disease-free survival in triple-negative breast cancer.
http://www.ncbi.nlm.nih.gov/pubmed/27029708
Ann Oncol. 2016 Mar 30. pii: mdw150. [Epub ahead of print]
Primary Analysis of a Prospective, Randomized, Single-Blinded Phase II Trial Evaluating the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence.
Mittendorf EA1, Ardavanis A2, Symanowski J3, Murray JL4, Shumway NM5, Litton JK4, Hale DF6, Perez SA2, Anastasopoulou EA2, Pistamaltzian NF2, Ponniah S7, Baxevanis CN2, von Hofe E8, Papamichail M2, Peoples GE9.
In patients with triple negative breast cancer (TNBC, HER2 IHC 1+/2+ and hormone receptor negative) DFS was 77.7% in vaccinated patients (n=25) vs. 49.0% in control patients (n=25), (P=0.12).
CONCLUSION:
The overall intention to treat analysis demonstrates no benefit to vaccination. However, the results confirm that the vaccine is safe and suggest that vaccination may have clinical benefit in patients with low HER2 expressing tumors, specifically TNBC. Further evaluation in a randomized trial enrolling TNBC patients is warranted.
Antigen Express has previously published its work on the development of a vaccine for potentially pandemic viruses such as the H5N1 (avian flu) and H1N1 (swine flu) influenza strains. The advantage of the technology is that it entails entirely synthetic production methods, which are rapid, cost effective, and flexible. The vaccine is produced using a small fragment derived from a target protein modified to ensure activation of CD4+ T helper cells. This cell type is critical in the generation of an effective immune response to a novel agent.
Ann Oncol. 2016 Mar 30. pii: mdw150. [Epub ahead of print]
Primary Analysis of a Prospective, Randomized, Single-Blinded Phase II Trial Evaluating the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence.
Mittendorf EA1, Ardavanis A2, Symanowski J3, Murray JL4, Shumway NM5, Litton JK4, Hale DF6, Perez SA2, Anastasopoulou EA2, Pistamaltzian NF2, Ponniah S7, Baxevanis CN2, von Hofe E8, Papamichail M2, Peoples GE9.
Author information
Abstract
BACKGROUND:
AE37 is the Ii-Key hybrid of the MHC class II peptide, AE36 (HER2 aa:776-790). Phase I studies showed AE37 administered with granulocyte macrophage colony-stimulating factor (GM-CSF) to be safe and highly immunogenic. A prospective, randomized, multicenter phase II adjuvant trial was conducted to evaluate the vaccine's efficacy.
METHODS:
Clinically disease-free node-positive and high-risk node-negative breast cancer patients with tumors expressing any degree of HER2 (immunohistochemistry (IHC) 1-3+) were enrolled. Patients were randomized to AE37+GM-CSF versus GM-CSF alone. Toxicity was monitored. Clinical recurrences were documented and disease-free survival (DFS) analyzed.
RESULTS:
The trial enrolled 298 patients; 153 received AE37+GM-CSF and 145 received GM-CSF alone. The groups were well-matched for clinicopathologic characteristics. Toxicities have been minimal. At the time of the primary analysis, the recurrence rate in the vaccinated group was 12.4% versus 13.8% in the control group (relative risk reduction 12%, HR 0.885, 95% CI: 0.472-1.659, P=0.70). The Kaplan-Meier estimated 5-year DFS rate was 80.8% in vaccinated versus 79.5% in control patients. In planned subset analyses of patients with IHC 1+/2+ HER2-expressing tumors, 5-year DFS was 77.2% in vaccinated patients (n=76) vs. 65.7% in control patients (n=78), (P=0.21). In patients with triple negative breast cancer (TNBC, HER2 IHC 1+/2+ and hormone receptor negative) DFS was 77.7% in vaccinated patients (n=25) vs. 49.0% in control patients (n=25), (P=0.12).
CONCLUSION:
The overall intention to treat analysis demonstrates no benefit to vaccination. However, the results confirm that the vaccine is safe and suggest that vaccination may have clinical benefit in patients with low HER2 expressing tumors, specifically TNBC. Further evaluation in a randomized trial enrolling TNBC patients is warranted.
"Street Junkie"
http://www.cnbc.com/2015/09/10/youll-never-guess-whats-killing-americas-teens.html
Ben was a typical high school sophomore. He lived with his family in a solid middle-class town in northern New Jersey, played football and loved to hang out with his friends on the weekends... Their son quickly moved beyond alcohol to pills and was soon crushing and snorting OxyContin to get a faster and stronger high. When the pills proved too expensive, he turned to heroin. By the time he was 18, Ben had been in and out of three drug rehabilitation centers, each time returning home to use again.
I'm rather surprised, you, WeeZuhl, are bothering to readdress an issue we both understand, is a non issue.
WeeZuhl call the HAL Labs.
Subtle... just like if Elite were to RM with Epic? That was soo upsetting when Dianne asked who you were repeatedly?
I got you figured..... WeeZuhl
And where does it say that the capsules were never opened in house or otherwise? Tablets too? And how to do that without cross contamination for the tablet. Not so easy.
The folks at Elite are not as smart as you? Okay.
Also explain to those more technically inclined how separation can be achieved and how the opioid abuse formulation Elite will so easily be defeated in a cost efficient manner as to undercut or be equal to street drug prices. Please contact Elite management immediately. This is a huge concern.
Provide a link that says they did not try any and all means.
HAL or in house.
The current stomach acid/lemon juice bead separation argument is just the latest straw man argument to antagonize longs, similar to predictions of 2 cent pps, etc. While I am pretty sure it will be more complicated than dissolving in acidic solution, I am also certain there will be an extraction protocol developed in short order as soon as these products hit the street. There really is no doubt about it, and to pretend otherwise is pure denial. The question is whether that process is multi-step, multi-component and complicated enough to require time, effort, and equipment and how pure/efficient the extract is.
Truth is nobody currently knows how to separate the beads or extract the agonist/antagonist, so don't buy it when somebody says they do- no matter how confidently the say it. But at the same time, understand that somebody will figure it out quickly. No ADF is perfect, that's why they're called "abuse deterrents" and not "abuse blockers". The goal is to erect substantial barriers to abuse, and ELTP 2 bead pharm-based ADF is best in class abuse deterrence. Tablets cannot be chewed, crushed, snorted, smoked, charred, or injected, and beads cannot be separated by color, size, weight, or density.
But the simple fact is that the process of separating them will be far too much of a pain in the butt, and an abuser will abuse the 2 bead product just like the other 90% of opioid abusers, by swallowing whole pills in tact.
ELTP 2 bead pharm-based ADF cannot be chewed, crushed, snorted, charred, smoked or injected; but a few whole tabs chased by bourbon feels real nice. Can we please dispense with sophist nonsense about anybody bothering to separate the beads?
...oral in tact ELI-200 is plenty abusable without going through the time and trouble to separate the beads. A few hardcore IV users will do it and a few hobbyist users will do it (i.e. college kids), but most will not bother- way too much trouble when swallowing it whole works just fine.
Not only will ELI-200 get approval, it will be best in class, as will every 2 bead pharm-based ADF that follows. But please do not misunderstand the technology. It does not prevent oral abuse, overdose, or addiction. And it will not be impenetrable, at least not for long.
... if you understand, like me, that this tech erects substantial barriers to abuse by some but not all measures, then hold on it should be awesome. Because even when 5 different protocols are published to defeat it, and they will be, it will still be best in class ADF. (Right up until something comes along that prevents oral abuse and overdose).
Everybody who owns this stock should ask themselves seriously: does it matter to my investment if someone figures out how to separate these beads? I did this exercise in 2013 as routine risk-assessment. I decided it is almost certain that somebody will figure it, and it does not matter- not one little bit. Still best in class, still modular across the entire range of opioids and time-release characteristics. But if an investor for some reason refuses to even consider the possibility that 2 different objects will be separable, then they do so at their own risk. They've been warned.
You provided the link yourself!
Link to that?
No one has proved the beads can be separated. Only wild theories. HAL studies proved otherwise. The FDA will go by the HAL studies, not message board theories.
HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, single-dose, five-way crossover to evaluate the relative bioavailability, abuse potential and safety of crushed intranasal ELI-200 capsules compared to the crushed intranasal comparator product, oral intact ELI-200, and placebo in 37 healthy male and female non-dependent recreational opioid users with intranasal experience. The primary objective was to assess the abuse potential of ground ELI-200 relative to the crushed comparator product when administered intranasally to non-dependent, recreational opioid users with intranasal experience.
The secondary objectives were:
To assess the abuse potential of crushed intranasal ELI-200 relative to placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
To assess the abuse potential of oral intact ELI-200 relative to crushed intranasal ELI-200, crushed intranasal comparator, and placebo (oral and intranasal) in non-dependent, recreational opioid users with intranasal experience.
To assess the relative bioavailability of the opioid in plasma from crushed intranasal and oral intact ELI-200 compared with one another and crushed comparator when administered intranasally in non-dependent, recreational opioid users with intranasal experience.
To assess the safety of crushed intranasal and oral intact ELI-200 compared with crushed intranasal comparator and placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
The full report from the HAL studies is expected in October.
HAL studies are included in the FDA's Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (January 2013). These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects and other qualities.
Saved from the deletion bin...
As for example Eudragit NE30D is commonly used for Extended Release drugs and is cited as an example by $ELTP ADT Patents for the Sequestering polymer
There is every reason to believe that the ER and sequestering polymers are exactly the same in order to prevent exploitation of the physical and electrical properties. It would be elementary from the beginning by $ELTP R&D person(s)to make certain.
Oh, I see.
$ELTP ADF Patents do not discuss the Extended Release Polymer used by $ELTP for their opioid agonist except to state that it is State of the Art. $ELTP has preferred to keep their sophisticated current ER Polymer technology as trade secrets. As well $ELTP Extended Release Polymers technology has FDA approval.
Quote:
Thus, any type of release profile known in the art, including but not limited to, immediate and sustained release formulations, may be used in accordance with the opioid-agonist layer of this embodiment.
Eudragits are commonly used as extended release polymers to control the active drug release. For $ELTP to design the "difficulties" for the agonist and antagonist beads separation it is most likley that they have used the same Eudragits for both the ER agonist and Sequestered antagonist.
Let's clear something up.
It has been incorrectly-posted on this board no fewer than 5 times in the past 48 hours (and by people who should know better) that the two beads are essentially identical except for the medicine they contain. This is absolutely incorrect- the two beads are completely dissimilar and have only been made to share the same physical characteristics.
FACT: Eudragit is used only as a SEQUESTERING POLYMER (nonreleasing layer) and only in the antagonist bead.
FACT: The agonist bead DOES NOT CONTAIN EUDRAGIT or any other nonreleasing layers.
FACT: The only similarities between the agonist bead and the antagonist bead are size, color, weight, and density. They are completely different in every other way.
Anybody who does not have a firm grasp of these 3 facts has more reading to do.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=PTXT&s1=%22elite+laboratories%22&OS=%22elite+laboratories%22&RS=%22elite+laboratories%22
The invention is also directed to a method of preventing the abuse of an oral dosage form of an opioid agonist. An embodiment of the method of the invention includes the forming of an oral dosage form by combining (1) a first type of pellet comprising an opioid agonist; and (2) a second type of pellet comprising: a biologically inert pellet; an opioid-antagonist layer coated on the biologically inert pellet, wherein the opioid-antagonist layer comprises a therapeutically effective amount of an opioid antagonist; and a non-releasing membrane coated on the opioid antagonist layer, wherein the non-releasing membrane comprises a water-retardant polymer
First, I always said it was theoretical. Duh, how could it be anything other? Clearly, physics is not your thing (or chemistry), but I have now offered 3 different theoretical ways in which the beads can be separated and could easily give at least 5 more. No one has offered any scientific criticisms other than people who misunderstand the science (you). Maybe none of them would work, but we are about to have thousands of very tenacious people trying to figure it out. If you can't wrap your mind around the concept that different things are different in a lot of ways, I cannot help you. But they are, and those differences can and will be exploited. Likewise, I'm not going to waste my time teaching you chemistry and physics and human nature, especially since you don't seem interested in anything other than being a smartass.
Oh, well, if Nasrat said it then what was I thinking?
I also recommend you go back and review the patents as you seem to have a fundamental misunderstanding of the non-releasing layer and how it works.
To be clear...what was stated is ridiculous. Hundreds....maybe thousands of physical properties? Ahhh ok....First of all, the chemical make up of these two beads is awfully similar with almost exclusively the same ingredients.
But hey....what do I know.
Simply wild speculation with zero proof as to what a "Street Junkie" can do with household appliances.
You are confusing Street Junkies expertise with sophisticated labs and high tech diagnostics. The FDA is aware of what high tech labs can do and so are $ELTP R&D professionals.
Imposing an electric charge concept thru an aqueous media thru a water retardant polymer without destroying the agonist by a "Street Junkie" is well...simply wild speculation.
More Cost Effective for Street junkies to abuse ARFs and following that, peddle Cocaine.
"water-retardant polymer" for the opioid agonist and antagonist
Since I am not a chemist and may have to rely on the one or two we have amongst us.....I'll continue the discussion with the following question:
Wouldn't introduction into water by adding an acid start the breakdown process and dissolving of both beads? By the time separation occures, leaking should have started via the antagonist and agonist.
Those chemicals you mention are common household products. If the experts, inorganic and organic chemist, pharmacist, street junkie hackers that work for various agencies such as Camargo hasn't been able to thwart Elite's 2 bead process via the HAL studies
perhaps whether the beads are able to be separated or not isn't going to detour Elite from getting Eli 200 approved.