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Flibanserin Risk Management Challenges: Can A REMS Prevent Alcohol Interactions?

 
• By Sue Sutter

FDA seeks advisory committee views on risk of hypotension and syncope with Sprout’s sexual dysfunction drug flibanserin when used alone or in combination with alcohol, and whether these risks outweigh ‘numerically small’ benefits over placebo.

The fate of Sprout Pharmaceuticals Inc.’s Addyi (flibanserin) for treatment of female hypoactive sexual desire disorder may hinge on whether, and how, the risks of a serious interaction with alcohol can be managed.

FDA briefing documents released ahead of a June 4 advisory committee review raise concerns about the clinically significant interaction between flibanserin and alcohol.

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