It's trial by fire for Zogenix, as painkiller Zohydro's launch meets public furor

No such thing as bad publicity? Zogenix ($ZGNX) might disagree. Preparing to roll out its powerful new painkiller, Zohydro, the company faces an outcry about its addictive potential. So, Zogenix is scrambling to defend itself and the drug, with promises of a tempered, careful launch.

Attorneys general, addiction specialists, even some members of Congress, are lobbying the FDA to yank Zohydro's approval. Newspapers across the country are running their own stories about locals worried that Zohydro will fuel a new round of painkiller-addiction problems. Some of those concerns were shared by an FDA advisory panel, which voted against Zohydro's approval.

Pain specialists and patients--not to mention the FDA--say that the drug will be a valuable addition to the pain-fighting toolbox. They also promise that it's safe when used as directed.

But the trouble is its potential allure for people who have no intention of following those directions. Zohydro is the first all-hydrocodone pain reliever to win FDA approval. Previous painkillers also included aspirin or acetaminophen, but Zohydro is pure opiate. It doesn't have tamper- or abuse-resistant features designed to thwart the crushing or dissolving necessary to unlock an extended-release formula's immediate high.

San Diego-based Zogenix is trying to combat the critics. Last month, the company said it had set up a committee of outside experts in pain management, addiction, and law enforcement, among others--an "External Safe-Use Board." It's also planning to educate patients, doctors, and pharmacists to not only recognize signs of abuse, but keep a lookout for black-market activity.

Its other safeguards directly affect salespeople. Zohydro reps' pay will be pegged to "achieving educational goals" rather than hitting script quotas, the company says. And reps will be targeting prescribers experienced in pain management, rather than a wide field of front-line docs. That's important, because recent research has shown that careless and irresponsible doctors are a linchpin of the painkiller-abuse problem.

So far, the FDA has remained firmly on Zogenix's side. The agency maintains that adding a new opiate to the painkiller mix is important for patients who aren't getting relief from other drugs. There's no sign that the lobbying effort will sway the agency to yank Zohydro's approval. Meanwhile, Zogenix is promising to develop a tamper-resistant version posthaste.

- read the Zogenix release
- get more from the Louisville Courier-Journal

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