Sprout’s female sexual desire pill is in the spotlight again as US regulatory advisors gear up to assess whether its benefit outweighs its risks.
Documents posted to the US Food and Drug Administration’s website ahead of a meeting of its advisory panels on Thursday note that the once-daily hormonal pill indeed provides a benefit for pre-menopausal women with low sexual desire, but also stress several safety concerns need ironing out.
In particular, FDA staff have cited concerns over fainting and depression observed in patients taking the pill in clinical trials, which could spell further trouble ahead for the drug.
Sprout picked up flibanserin from Boehringer Ingelheim in 2011 after it was originally rejected by the FDA the year before. Despite being resubmitted in June 2013 with additional safety and efficacy data, the agency issued another complete response letter five months later, citing side effects, sparking another round of trials.
