The FDA has to approve Zohydro because their fingerprints are all over this program. They argued for the need because of tylenol toxicity, it met all endpoints, including safety. If the FDA denied it's approval they will send shockwaves throughout the industry. The FDA showed it's hand when it requested more time. The FDA is hammering out an improved REMS with Zogenix. Guaranteed.
The FDA can reject Zohydro based on political pressure and influence if they're willing to reimburse Zogenix for all their costs/expenses during the developmental process. But we know that's never going to happen. You are right about the FDA's fingerprints all over Zohydro. It'll be very interesting come May.
For Immediate Release: April 16, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397; firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves abuse-deterrent labeling for reformulated OxyContin
Agency will not approve generics to original OxyContin
"The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting. However, abuse of OxyContin by these routes, as well as the oral route, is still possible. The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube. When FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also."
Zohydro is not a generic, but rather a single-entity extended-release hydrocodone that will be misused and abused just like any other opioid drug with/without deterrent properties. This is the reason for the REMS prescriber training on all opioid drugs.
I've read your posts in other forums, bio, and you definitely know your subject. But I think approval will create a bigger firestorm, mostly political. All the FDA's "encouragement" to develop abuse resistant formulations with specific guidance will mean absolutely nothing if they approve a "controversial" drug w/o TRF. Precedent will be set. No need for manufacturers to jump through hoops in the future if the FDA rules that REMS and schedule II are enough to deal with the priority of combating abuse. The FDA will have no teeth if they communicate a "do as we say, not as we do" message. As a result there would be a flood of laws and regulations from Congress controlling health care even more then we're seeing now IMO.
I keep flipping on this. first the oxy news looked like a foreshadow, now it looks like a headfake.
I reckon i have some pocket change to gamble . In the long run the Zog will go back over 2.00 with or without zohydro's immediate fate.