Women’s Intuition: What Approval Of Sprout’s Addyi Means For Sponsors
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.
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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.
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.
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.