Flibanserin Risk Management Challenges: Can A REMS Prevent Alcohol Interactions?
This article was originally published in The Pink Sheet Daily
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.
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Filing for a drug with questionable risk-benefit profile was saved by a trial protocol redesign, strict safety labeling for a narrow indication, a REMS, patient mobilization and plenty of postmarketing studies. Trial period echoes FDA’s approach with a similar sector of lifestyle drug: obesity.
As company gears up for an Oct. 17 launch, with pricing on par with Viagra, commercial challenges include a contraindication and boxed warning against alcohol use.
Panel’s vote to approve Sprout’s female sexual dysfunction drug is conditioned on a REMS and possible contraindication with alcohol use; questions about drug’s date rape potential, breast cancer finding in mice addressed.