US approves AMAG's Vyleesi for women with hypoactive sexual desire disorder

The FDA on Friday approved AMAG Pharmaceuticals' Vyleesi (bremelanotide) to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. The decision makes Vyleesi only the second approved therapy for HSDD in the US after Sprout Pharmaceuticals' Addyi (flibanserin), which entered the market in 2015.

According to the FDA, the effectiveness and safety of Vyleesi were evaluated in two randomised Phase III RECONNECT trials involving 1247 premenopausal women with acquired, generalised HSDD. The agency said most patients used Vyleesi two or three times per month and no more than once a week. The drug is self-administered via an auto-injector pen in the thigh or abdomen at least 45 minutes before anticipated sexual activity.

Results from the studies showed that about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score, compared to about 17% for placebo. Further, roughly 35% of Vyleesi-treated patients experienced a decrease of one or more on a "distress" index, where higher scores indicated greater distress from low sexual desire, versus about 31% of those who took placebo. The FDA noted that there was no difference between treatment groups regarding change from baseline in the number of satisfying sexual events.

Meanwhile, the most common side effects of Vyleesi were nausea and vomiting, flushing, injection site reactions and headache. AMAG noted that the majority of events were transient and mild-to-moderate in intensity.

"We're obviously thrilled about being able to bring another option to patients," said Julie Krop, chief medical officer at AMAG, adding that "these women have suffered significantly, pretty much in silence, for a stigmatised condition, and many of them have not known that it’s a treatable medical condition."

AMAG in-licensed Vyleesi in 2017 from Palatin Technologies, which will receive a $60-million payment as a result of the FDA approval. In addition, the deal calls for AMAG to pay Palatin tiered royalties on annual net sales of Vyleesi.

Meanwhile, in April, the FDA loosened alcohol restrictions on Addyi, although it cautioned that there were still concerns about consuming alcohol close in time to taking Sprout's drug. The company agreed to be acquired by Bausch Health, formerly Valeant Pharmaceuticals, shortly after the FDA had approved Addyi in 2015. However, former Sprout shareholders later accused Bausch of mismanaging the marketing of Addyi, with Bausch eventually selling Sprout back to its former owners in exchange for a royalty on global sales of the HSDD drug beginning in May 2019.

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