Sexual dysfunction treatment approved by FDA

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A new drug for female sexual dysfunction has received approval from the US Food and Drug Administration (FDA). Bremelanotide is an injectable indicated for premenopausal women with hypoactive sexual desire disorder (HSDD).

Marketed under the name Vyleesi, the drug is administered by patients via prefilled autoinjector at least 45 minutes before anticipated sexual activity. A woman can decide the optimal time for use based on her experience of duration of benefit and any side effects.

Bremelanotide received the nod from the FDA based on results from two 24-week, randomized, double-blind, placebo-controlled trials. The participants were 1,247 women with generalized HSDD most of whom used the drug two to three times per month but no more than once a week.

In the studies, sexual desire scores (range 1.2 to 6.0) increased by 1.2 or more in approximately 25% of the women who used bremelanotide versus 17% of those on placebo, which was statistically significant. About 35% of women treated with the drug also had a decrease of ≥ 1 in distress score (range 0 to 4), a statistically significant reduction. (Higher sexual desire scores indicate more desire whereas higher distress scores indicate more distress from low sexual desire.) No change was seen in either group in number of satisfying sexual events, which was expected because bremelanotide does not enhance sexual performance.

The most common side effect seen in the trials was nausea (40% incidence), most commonly with the first injection, and 13% of the women needed an antiemetic to treat it. Focal hyperpigmentation of the face, gingiva and breasts was seen in about 1% of patients, which did not resolve in half the patients after stopping treatment and was more likely to occur in dark-skinned women. Bremelanotide is contraindicated in patients with hypertension because immediately after use, the drug has been shown to increase blood pressure.

In a press release on its website, the manufacturer of bremelanotide said the drug will be available commercially in September at select specialty pharmacies. No information was provided on cost. A registry has been established to monitor for pregnancy outcomes in women exposed to bremelanotide.