Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Sounds like a sucker's bet.

Need to increase your sale/buyout price.

https://www.raps.org/news-and-articles/news-articles/2019/9/fda-consults-on-abuse-deterrent-cns-stimulants

Thanks.

Abuse-deterrent ADHD drugs sounds like a solution looking for a problem. Most studies suggest that a very small percentage of abusers crush and then snort or inject these drugs. ADHD drugs are widely abused, but a vast majority of abuse is swallowing whole pills by people without a true ADHD diagnosis and without a legitimate prescription. So just like opioids, ADF versions of ADHD drugs would not prevent the most common forms of abuse. So why does the FDA want ADF ADHD drugs?


When I see the FDA asking questions about ADF ADHD drugs, while I know damn well that very few individuals are snorting or injecting these drugs, then I ask myself who is behind this and why? The answer to the second question is easy because it is always the same answer: MONEY. This is exactly the same way Purdue maintains their monopoly on OxyContin. They sold the non-ADF version right up until the second that generic manufacturers started winning in patent courts. Widespread abuse and mortality is not what gave birth to ADF OxyContin, but rather, it was the impending approval of generic versions. In 2010, Purdue introduced the ADF version of OxyContin, and the FDA compliantly declared the old non-ADF version was discontinued for "safety" reasons, thus making it impossible to make a generic version and ensuring Purdue's OxyContin monopoly that exists still to this day. So that helps to answer the first question about who would be behind this. Again, follow the money.


Brand name Concerta (methylphenidate ER) has a special formulation called "OROS" (osmotic-release oral system), but the generic versions of Concerta do not use OROS. The manufacturer, Mannheim, has always inferred that the OROS formulation makes it very difficult to extract MPH for abuse. And I suspect it does. I would bet that brand name Concerta, without any further modification, could do pretty well in a HAL snorting study and would perform much better than its generic equivalents in extraction studies for simulation of IV abuse. I would bet brand name Concerta would qualify for an ADF label as it exists right now, and I would bet every one of the generic versions of Concerta would fail the exact same HAL studies. Under this scenario, it would not be far-fetched to see FDA keep brand name Concerta while discontinuing the generics.


ADF ADHD drugs would be far more likely to hurt Elite than help it. It would much more likely result in some Big Pharmas having exclusivity on brand name ADF versions and all generic versions (including Elite's) being pushed off the market for bullshit "safety" reasons.


On a side note: even when taken as prescribed by properly-diagnosed individuals, ADHD drugs present major challenges and side effects. For those who are interested, there is an excellent documentary on Netflix called Take Your Pills. It does a pretty good job of showing both sides of the coin without being judgmental or preachy.