Replies to post #187033 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

Sounds like the only hesitation is how quickly they can get ADTs on the market ASAP and discern their effectiveness over non ADT opioids.

Changing course: A new approach to opioid pain medication at FDA

http://blogs.fda.gov/fdavoice/index.php/2016/02/changing-course-a-new-approach-to-opioid-pain-medication-at-fda/

First, we’re going to be more transparent and open in the approval process for this category of drugs. Starting today, the FDA will convene an expert advisory committee before approving any new drug application for an opioid that is not in an abuse-deterrent formulation (ADF).

Finally, we’re going to focus efforts on approving drugs that have the potential to help mitigate the crisis. That means spurring the development of promising generics with abuse deterrent formulations. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. We believe the availability of less costly generic products should accelerate prescribers’ update of abuse deterrent formulations.

But it’s time for us to act – to take the first steps toward changing how we do business and addressing this problem.

[richme]

Two certain known facts regarding opioid abuse. 1) dead once, there is no repetition; 2) abusers are not paying attention to the risks and dangers of opioid abuse.

Three weeks ago, I had surgery for a hernia repair. I got the usual 20 hydrocodone tablets and decusate. Used 8 hydrocodone tables and destroyed the rest. I read long ago that as little as 20 tablets can lead to addiction.