With its potential for addiction and its lack of abuse-deterrent features, Zogenix's Zohydro painkiller had its critics even before its regulatory green light in October. Now, with the powerful product on the market, a coalition of activists is taking its protest to the next level.
The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.
Pharma naysayers have been known to accuse the industry of making drugs that cause side effects--and then making more drugs to treat those side effects. Now, a group of critics is taking aim at Zohydro, the new painkiller approved by FDA last month.
The FDA has approved Zogenix's pain med Zohydro ER, sending its shares soaring on the reversal of fortunes for a drug that had been rejected by an expert panel late last year.
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
When an FDA expert panel recommended against a stronger form of hydrocodone from Zogenix ($ZGNX) this month, it said it was best if the FDA would first consider requiring ways to discourage abuse of opioids. The agency intends to do just that.
After its pain drug was shot down in a lopsided vote among FDA experts on Friday and analysts weighed in with a dour assessment of its chances at the hands of regulators, investors exacted their revenge on Zogenix today by wiping out half of the company's share price.
There is abuse of power and then there is power over abuse and that is what an FDA panel exercised Friday when they recommended against a stronger form of hydrocodone from Zogenix ($ZGNX), citing its potential for illegal use by drug addicts.
San Diego's Zogenix has taken another step in expanding its DosePro needle-free delivery system, signing a co-promotion agreement with Mallinckrodt, a division of Covidien.
The FDA wants to look over painkillers that include the ingredient known as hydrocodone amid an increase in abuse and federal drug agents' ongoing call for stricter prescribing guidelines, Bloomberg reported.