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.