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Zogenix pain drug may be abused at higher rate, FDA staff says

Zogenix Inc.'s pure hydrocodone painkiller Zohydro may be abused at a greater rate than combination products on the market, U.S. regulators said.

Food and Drug Administration staff asked outside advisers to weigh the effectiveness of the extended-release pill against its risk of abuse. The advisory panel will meet Dec. 7 to decide whether to recommend the medicine's approval.

Zogenix (Nasdaq: ZGNX), whose $38 million in revenue last year came from its migraine injection Sumavel, may get more than $200 million in sales of 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.

The FDA is scheduled to decide whether to clear the painkiller by March 1 and doesn't have to follow the panel's recommendations.

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1 UserComments
Fat Chance 7:30pm December 5, 2012

Good point, 4x the abuse rate without tylenol. Sounds like nothing will happen. happy times selling SDP. Company is going to sink without zohydro.

Zogenix Inc.

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12400 High Bluff Dr. Ste., 650
San Diego, CA 92130

Zogenix Inc. Executive(s):

Roger Hawley

  • Chief Executive Officer

Stephen Farr

  • President

Ann Rhoads

  • Chief Financial Officer