FDA review of flibanserin for Hypoactive Sexual Desire Disorder in pre-menopausal women - Sprout Pharma

Flibanserin, an investigational, once-daily, non-hormonal pill for Hypoactive Sexual Desire Disorder in pre-menopausal women has adverse effects giving concern at the FDA which is reviewing a submission from Sprout Pharma. These adverse events are syncope (fainting) and hypotension, especially syncope when the drug is used concomitantly with alcohol or when flibanserin is used with CYP3A4 inhibitors. In an alcohol interaction study, 16% of participants experienced significant events of severe hypotension and syncope within 1.5 to 4 hours of taking the pill with alcohol.The FDA has convened a joint meeting of the FDA Bone & Reproductive and Urologic Drugs (BRUDAC) advisory committee and The Drug Safety and Risk Management Advisory Committee (DSaRM) to advise as to whether the benefits of flibanserin outweigh its risks which is planned for 4 June 2015.