Zogenix, Inc. Drug May be Abused at Higher Rate, FDA Staff Says

Published: Dec 05, 2012

Zogenix Inc. (ZGNX)’s pure hydrocodone painkiller Zohydro may be abused at a greater rate if approved than combination products on the market, U.S. regulators said. Food and Drug Administration staff asked outside advisers in a report today to weigh the effectiveness of the extended- release pill against its risk of abuse. The advisers will meet Dec. 7 to decide whether to recommend the medicine’s approval. Zogenix, whose $38 million in revenue last year came from migraine injection Sumavel, may get more than $200 million in sales from Zohydro, Annabel Samimy, a Stifel Nicolaus & Co. analyst in New York, said in a note to clients last month. Zogenix, based in San Diego, touts Zohydro as the only pure alternative to hydrocodone-combination painkillers, such as the acetaminophen-mixed Vicodin, which carry a risk of liver injury. “It is expected that Zohydro ER (if approved and marketed) will be associated with higher levels of abuse than the hydrocodone combination products,” the FDA staff said in the report. Zogenix fell 4.7 percent to $2.41 at 9:17 a.m. New York time.

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