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Zogenix Faces Abuse Questions in Review of Pain Drug


The drug maker is making its case before a review panel ahead of an FDA approval decision for an experimental painkiller. Panelists will weigh potential for abuse.


A panel review of Zogenix's (NASDAQ:ZGNX) experimental drug for chronic pain on Friday will weigh the potential for abuse of the medicine.

The company's Zohydro ER is an extended-release capsule containing the painkiller hydrocodone. Zogenix applied for US approval of the drug in May for dosing every 12 hours. On Friday, a panel of expert advisers to the Food and Drug Administration will review the drug and make a recommendation on whether the treatment should be cleared for sale. The FDA is expected to make a decision by March 1.

Hydrocodone is one of the active ingredients in Vicodin. Like oxycodone, it is a narcotic and already considered by the government as a risk for drug abusers.

"If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products," FDA staff reviewers wrote in a report for advisory committee members this week.

Shares of Zogenix dipped this week but the stock is still up 24% over the past six months, closing Thursday at $2.36.

Click here for the draft questions for the advisory committee. The meeting begins at 8 a.m. ET Friday. It is webcast here.

(See Celgene, NPS Pharmaceuticals, Amarin, J&J, Medivation Among Stocks to Watch in December.)

Twitter: @brettchase

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