Now Sprout Has To Sell Female Sexual Desire Drug Addyi
This article was originally published in The Pink Sheet Daily
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.
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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.
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.
Experts convened by FDA to discuss female sexual dysfunction disorders, including problems with desire and arousal, settle on endpoints contrary to new DSM, but are in line with trials of Sprout’s flibanserin, the leading drug in development.