A U.S. Food and Drug Administration panel has voted against the agency approving Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. In an 11-2 vote, the advisory panel said Zogenix had met FDA standards for safety and efficacy, but cited concerns about the danger of addiction posed by the opioid drug class, according to this article.
The FDA could still approve the drug for sale in the United States by imposing restrictions to protect public safety, though it usually follows the advice of its advisory panels when deciding whether to approve new medicines. Agency officials will consider the committee’s recommendation in deciding by March 1 whether to give Zohydro the green light, the article says.
San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)
Other pharmaceutical companies – including OxyContin maker Purdue Pharma – are already working on their own versions of Zohydro. Hydrocodone is currently the second most-abused medicine in the U.S. behind oxycodone.