Replies to post #204125 on Elite Pharmaceuticals Inc (ELTP)

[rollin2nyte]

That's incorrect. The goal is to make these drugs abuse deterrent and waiting for abuse proof formulations is only going to compound the opioid problem. ADF's are a classic example of progressive elaboration.

[Don'tDrinkTheKoolAid]

No such thing as oral abuse as the drug wouldn't work if you prevent it from working HUH?. As mentioned before anyone can OD on anything if you take too much. IE: sleeping pills Motrin etc. Now oral abuse by chewing for faster high yes ELI200 prevents that.

[Couch]

Nope - if Pfizer gets the ADT label - ELTP should get the ADT label.

Pfizer's ALO 02 is an ER - Eli 200 is an IR product. There are no ADT labeled IR products on the market period. Elite would be the first.

[WeeZuhl]

This is a trick question.

if the fda gives Sequestox the same approval as PFE's drug (I.e., adt labeling for iv and nasal but not oral), it's not going to help us - we need all 3 adt labels (iv nasal oral) to be profitable.

Right?

SequestOx does prevent oral abuse by chewing/sucking, but it will not have labeling for oral abuse. When the FDA is referring to oral abuse, they are referring to an abuser's ability to tamper with an ER/LA drug and thereby turn it into an immediate-release drug. Since SequestOx is already an immediate-release drug, this question is irrelevant to SequestOx, and an oral abuse label will not even be an option. It will be an extremely relevant question, and a very important part of the ADF label, for ELI-201 and ELI-216, but not IR ELI-200. As far as I'm aware, there were only nasal abuse studies done for ELI-200 (B. Setnik's poster), and I have never seen any oral abuse data for any ELI drug.