FDA approves 'female Viagra' though impact could be limited for patients and market

The US Food and Drug Administration has approved the first drug to treat sexual desire disorder in premenopausal women, Addyi (flibanserin) from Sprout Pharmaceuticals.

It is a once-daily non-hormonal oral drug for generalized hypoactive sexual desire disorder in premenopausal women. It has been approved with a box warning about the risks of severe hypotension and syncope in patients who drink alcohol, those who use moderate or strong CYP3A4 inhibitors and in patients with liver impairment.

The decision to clear the drug for marketing follows a majority vote by an advisory panel in June recommending Addyi for approval (The Pharma Letter June 5), and is based on three randomized Phase III trials in around 2,400 premenopausal women with acquired generalized HSDD who submitted self-reports of satisfying sexual events, sexual desire over the preceding four weeks and distress related to low sexual desire. Compared to placebo, treatment with Addyi increased the number of satisfying sexual events by 0.5 to 1 additional event per month.