Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Tilator- Take a look at what happened at PTIE Remoxy Adcom when they went in with good results and no partner and then get back to me.

Remoxy's failure had nothing to do with partnership and everything to do with crappy chewing data. When Remoxy is chewed, it acts like OxyIR and releases all of its oxy immediately, just like OxyContin (see below). This is why OxyContin does not have the chewing ADF label. And this is what I've been pointing out on this board ever since the Rexista's failed AdCom-- if Rexista dose dumps with chewing, like every other PEO-based ADF oxycodone ER, then it will, once again, be voted down at AdCom and rejected by FDA. Now that Collegium's Xtampza has the chewing ADF label, there will be no new oxycodone NDA approvals that do not qualify for it. Rexista, which is PEO-based and can be chewed "like bubblegum" according to Dr. Odidi, is very unlikely to do well in the chewing HAL studies. As I previously argued, the poisonous blue dye was not a superfluous add-on gimmick, it was a necessary component of the chewing abuse-deterrence, and without it, Rexista doesn't have any significant chewing abuse resistance. It may have a future life as a generic OxyContin ANDA, but as a new drug NDA, it is cold and dead. No partnership or approval will be forthcoming in 2019, 2020, or ever. Remoxy is proof of that. Of course, that doesn't prevent the company from wasting millions of dollars on legal fees, HAL studies, etc etc.


It's been over 1 year since IPCI committed to doing the oral abuse studies. I wonder why we haven't seen any results yet. (Just kidding, I know why.)