FDA Panel Votes Against Recommending Zohydro for Approval

A panel of experts assembled by the U.S. Food and Drug Administration (FDA) voted against recommending approval of the painkiller Zohydro ER on Friday. The panel cited concerns over the potential for addiction, Reuters reports.

FDA officials said they could still approve the painkiller by imposing safety restrictions.

In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone. Zohydro contains the opioid hydrocodone. Unlike some hydrocodone products such as Vicodin, Zohydro does not contain acetaminophen.

The FDA will decide by March 1 whether to approve Zohydro for sale in the United States for people who need an around-the-clock painkiller for an extended period.

Emergency room visits related to hydrocodone have soared since 2000.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” Stephen Farr, PhD, President and Chief Operating Officer of Zogenix, said in a statement. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”

In a letter sent to FDA Commissioner Margaret Hamburg, MD, before the panel vote, Steve Pasierb, President and CEO of the Partnership for Drug-Free Kids urged the agency not to approve Zohydro ER without requiring it to have tamper-resistant features. “If all extended-release opiate products were required to incorporate tamper-resistant technology, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses, and fewer deaths,” he wrote. “As a public policy matter, we should all be encouraging companies to ‘retrofit’ their current products so that they are more difficult to abuse. And we certainly should not be approving any new opiates without these protections.”