One interesting thing to note here is that after the panel voted to not approve Zohydro, FDA officials did actually say that approval was still possible if proper restrictions were in place. Perhaps the delay is meant to give the FDA more time to smooth out the REMS with Zogenix.
After all, the FDA did not require further information from Zogenix and that means the FDA is satisfied with all the data on Zohydro.
That's the million dollar question. For sure the FDA is waiting on something. If there were going to be a rejection or CRL, they could have just done that. The real question is what are they waiting on? Some people feel it is the Opana ER issue. Some feel it is the STOPP act? The longer the wait the more reasons to reject could "pop" up. So.....
B.S...There is no way they will approve it in its current form. I would bet that its was a short sell game to begin with. Adding a componet to this drug means it to has to be approved and studied. If it was that easy they would have done it on the first go around. They need to put Zohydro on the market for one reason, and that's to preserve LIVERS!!!, but unless there is a componet that will stop the possible abuse factor...I believe there is no hope. Without Zohydro, ZGNX will fall below a buck or worse.
Even if we think abuse resistant formulations are not effective, the FDA wrote up specific guidelines for developing these formulations with the encouragement of "fast tracking" approval for those pain killers that have them. Also they said they will make a decision by May if generics will be required to have abuse resistance or not. The FDA needs to be consistent with all this. The same decision must be made for generic opiods as it is with Zohydro and those opiods currently being tested. I don't know how all this can be decided in "several weeks".
Ok. I will google this Opana and STOPP issues.
What makes me curious is, that for every delay FDA gives some hints regarding issues. And a clear timeframe e.g. 3 months or 6 months. But in this case nothing was given, just two obscure words: several weeks.
Thanks and beste regards,