Summary

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• Vyleesi (bremelanotide) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.
• This summary is based on the review of four randomized controlled trial(s). ^[1-4]
• Bremelanotide significantly increased FSFI-desire scores and reduced distress related to low sexual desire in premenopausal women with HSDD, as demonstrated in the phase 3 RECONNECT studies, with sustained improvements observed during a 52-week open-label extension.
• Statistically significant improvements in sexual desire and distress reduction were consistent across various subgroups, including differences in age, weight, BMI, bioavailable testosterone levels, and irrespective of hormonal contraceptive use and HSDD duration.
• Bremelanotide did not have any direct comparative effectiveness data against other drugs in the studies provided.
• Nausea was the most common adverse event (40.0% in phase 3 studies), with some cases leading to discontinuation.
• Other notable adverse events included flushing (20.3%), headache (11.3%), and injection site reactions (5.4%).
• Serious adverse events were rare, with no deaths reported, and small, transient but statistically significant increases in blood pressure were observed.
• Focal hyperpigmentation occurred in more than one-third of subjects with consecutive daily dosing up to 16 days.
• No new safety signals were observed during the 52-week open-label extension phase, with most treatment-emergent adverse events being mild to moderate in intensity.