The FDA approved a powerful new painkiller from Zogenix ($ZGNX) despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.
Zohydro, which won the FDA nod in late October, is the first hydrocodone-only drug approved in the U.S. Other drugs, namely Vicodin and its generics, combine hydrocodone with acetaminophen, the active ingredient in Tylenol. Plus, Zohydro is an extended-release formula that contains a hefty amount of the active ingredient--and has no abuse-deterrent features that would prevent abusers from crushing it for snorting or injection.
And that's what worries these attorneys general, who have been wrestling with painkiller addiction in their states. In a letter to FDA Commissioner Margaret Hamburg, the AGs asked the FDA to withdraw its approval--or at least set a "rigorous timeline" for Zogenix to reformulate Zohydro with abuse-deterrent features.
Drugmakers, politicians, and law enforcement and patient groups have been lobbying the FDA to require all narcotic painkillers to be formulated to deter abuse. In the companies' case, it's somewhat self-serving; Purdue Pharma pulled its original formula of OxyContin (oxycodone), the notorious "hillbilly heroin" that touched off a wave of abuse, and introduced an abuse-deterrent version in its place.
Endo Health Solutions ($ENDP) also sells its powerful Opana ER (oxymorphone) in an abuse-deterrent formulation. After rolling out their new formulas, both companies tried to persuade the FDA not to approve generic versions that lacked similar protections. Purdue succeeded; Endo did not. Since then, Purdue has inked a patent settlement with Actavis ($ACT) allowing the generics maker to launch a tamper-resistant version of OxyContin at the beginning of next year.
Experts aren't optimistic that the AGs' protest on Zohydro will have any effect. After all, the FDA advisory panel that voted against Zohydro's approval asked the FDA to consider requiring tamper-resistance to be built in from the get-go. "I am glad to see Attorneys General making their case directly to the FDA, but if the agency doesn't respect its own committee of experts, I doubt a letter will change their decision," Dr. David Juurlink, director of pharmacology and toxicology at the University of Toronto, told MedPage Today.
But the FDA is urging drugmakers to develop more tamper-resistant meds to meet the needs of patients suffering from chronic pain. "The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs at FDA's Center for Drug Evaluation and Research, said when the FDA announced the ban on non-tamper-resistant OxyContin generics.