Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

I disagree.

What everyone needs to understand is that the FDA is always changing what is needed during the approval process, this is no way in any fault of Elite's.

I'm a fan of your posts, Winechemist, but I have to push back on this claim a little bit. Elite did have an opportunity to get SequestOx approved without the IV abuse studies, but that window of opportunity closed on April 26, 2017 when the FDA approved Roxybond with the IV and snorting ADF labels. Nasrat knew on that day, or should have known, he would need to do the IV abuse studies. If he didn't know it then, he definitely should have known by July 26, 2017, when IPCI showed up at Rexista AdCom without chewing or snorting abuse studies, and Dr. Odidi went home with his tail between his legs. FDA has not changed. They have been very clear that they will not approve any new opioid that is not at least as abuse deterrent as other available products. The 2.5 years wasted on the zombie formula allowed another company to sneak in and get the first IR ADF label, including the IV abuse label, and that is why it is not correct to say this is not in any way Elite's fault. This is just another cost of the fateful decision to go forward with a flawed formula instead of fixing it in the first place.


I don't think Nasrat was as surprised by this "new" requirement as he lets on, and if he was, that's kind of amateur. He is being disingenuous, in my opinion, but I don't know why. I do know he wasn't waiting all that time so the FDA could tell him how to run a fed & fasted pivotal BE. I think he was probably trying to convince the FDA that the IV studies weren't necessary, and he was unable to convince them to change their mind.


He actually has a pretty good case that the experiments have already been done and shouldn't need to be redone. For antagonist ADF's like SequestOx, the IV abuse studies are different than for physical barrier ADF's like Roxybond. Roxybond had to prove it is very difficult to get the drug dissolved and into a syringe. SequestOx still retains 100% of its ADF features despite being readily dissolved and easily drawn into a syringe, so it has to prove that the oxycodone cannot be extracted away from the naltrexone. But the FDA already knows it CAN be extracted, and they already know exactly how. Basically, crushed SequestOx = crushed Troxyca. Pfizer's Troxyca (oxyER/naltrexone) had some extraction issues for intact pellets that SequestOx should not have, because the Troxyca's naltrexone is contained in an inner core, while SequestOx naltrexone is in a separate bead. In my opinion, Nasrat's argument to the FDA was not that SequestOx IV abuse studies shouldn't be done; his argument was that they already are done:



https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM505122.pdf


Page 53:

Alternatively, common solvents A and L to N, are generally unable to extract oxycodone
from naltrexone selectively in crushed pellets. One unique exception appears to be the
use of Solvents F, G, H and O on crushed pellets, which selectively extracts naltrexone
from oxycodone. Of the common solvents I and P, solvent P selectively extracts the
oxycodone in a manner that appears dependent on the intrinsic solubility of the two APIs,
not on the delayed release of naltrexone by the sequestering membrane. This is further
supported by the ability of solvent P to selectively extract oxycodone even in crushed
tablets. Solvents I appear to extract oxycodone selectively from crushed tablets