UPDATED: Activists ratchet up fight for FDA to yank pain pill Zohydro's approval

With its potential for addiction and its lack of abuse-deterrent features, Zogenix's ($ZGNX) Zohydro painkiller had its critics even before its regulatory green light in October. Now, with the powerful product set to hit the market in March, a coalition of activists is taking its protest to the next level.

On Wednesday, the Fed Up! Coalition sent a petition to FDA Commissioner Margaret Hamburg calling on the agency to reconsider approval of Zohydro, the only hydrocodone-only drug approved in the U.S.

"In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the petition reads. " … We urge you to exercise your authority and responsibility to protect the public's health by keeping Zohydro off the market."

Fed Up! is not the first to warn the agency about Zohydro's risks. The petition follows a December letter from 28 attorneys general asking the FDA to withdraw the drug's approval--or, at the least, set a "rigorous timeline" for Zogenix to reformulate the med with abuse deterrents. The agency's own advisory committee also cautioned against a regulatory thumbs up, voting 11-2 to recommend that the FDA turn down the drug.

More and more, the FDA has found itself in a new role as pain med police, with politicians, health professionals and citizens looking to the agency to use its powers to curb opioid abuse. Last year, the agency took a number of steps to address public safety concerns, including blocking generics of the oft-abused OxyContin. That move leaves OxyContin's maker in charge of that market with its new abuse-deterrent formulation.

Zohydro comes with a new warning; it's the first drug to bear the label now required for all long-acting opioid analgesics, which the FDA says clearly describes the appropriate use of the meds along with their associated risks and safety concerns.

But the new labeling has hardly placated critics, who point to Zohydro's pure hydrocodone formula, extended-release properties and sheer potency as serious red flags.

"After the release of similar high-dose opioid analgesics, thousands of lives were lost from overdose and hundreds of thousands of medical and non-medical users became addicted," Fed Up! petition drafters wrote. "We implore you to take these painful lessons into account."

- see the petition
- get more from Medical Marketing & Media

Editor's note: This story has been corrected to reflect that Zohydro is set to hit the market in March.

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