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Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed

 
• By Brenda Sandburg

Advisory committee votes 18-6 to recommend approval of the female sexual dysfunction drug contingent on a risk management plan, despite unease about modest efficacy and risks such as fainting.

An FDA advisory committee recommended approval of Sprout Pharmaceuticals Inc.’s Addyi (flibanserin) for treatment of female hypoactive sexual desire disorder (HSDD) despite reservations about the drug’s minimal clinical effect and risks of hypotension and syncope.

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• By Kevin Grogan

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More from North America

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• By Cathy Kelly

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• By Sue Sutter and Derrick Gingery

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• By Michael McCaughan

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