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US clears Sprout Pharmaceuticals’ Addyi as first drug for female sexual desire disorder

Wed, Aug 19, 2015

Clinical News Room


The FDA on Tuesday cleared Sprout Pharmaceuticals’ once-daily non-hormonal oral drug Addyi (flibanserin) for generalised hypoactive sexual desire disorder (HSDD) in premenopausal women, with the agency noting it is the first FDA-approved drug available to treat sexual desire disorder in either men or women. The decision follows a majority vote by an advisory panel in June recommending Addyi for approval.

The US regular stated that Addyi is being approved with a boxed warning about the risks of severe hypotension and syncope in patients who drink alcohol, in those who use moderate or strong CYP3A4 inhibitors and in patients with liver impairment. The therapy, which is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, is also being approved with a risk evaluation and mitigation strategy, which includes elements to assure safe use, because of the increased risk of severe hypotension and syncope due to the interaction with alcohol. Prior to the FDA advisory panel vote, an agency staff report had questioned whether the drug’s benefit sufficiently outweighed its side effects.

In its decision, the FDA said the effectiveness of Addyi was evaluated in three randomised Phase III trials involving about 2400 premenopausal women with acquired generalised HSDD who submitted self-reports of satisfying sexual events, sexual desire over the preceding four weeks and distress related to low sexual desire. Results indicated that compared to placebo, treatment with Addyi increased the number of satisfying sexual events by 0.5 to 1 additional event per month, raised the sexual desire score by 0.3 to 0.4, and decreased the distress score related to sexual desire by 0.3 to 0.4.

Sprout refiled its application for Addyi earlier this year with additional data after the FDA reaffirmed its decision to reject the drug in 2014. The agency also refused to approve the therapy in 2010 after an advisory panel had unanimously voted against recommending clearance of the drug, which at the time was being developed by Boehringer Ingelheim.

FirstWord Pharma, 08-19-2015

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