Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder

This open-label extension study evaluated the long-term safety and efficacy of bremelanotide 1.75 mg subcutaneous in premenopausal women with hypoactive sexual desire disorder (HSDD), providing follow-up data of up to 52 weeks of continuous use. Participants were from the two pivotal RECONNECT phase 3 trials.

Safety results were reassuring:

• No new safety signals identified during prolonged use
• The incidence of nausea, the main adverse effect, progressively decreased with continued use
• No clinically significant impact on blood pressure or heart rate
• No evidence of tachyphylaxis (loss of effect) over time

From an efficacy standpoint, the extension demonstrated that benefits in sexual desire and distress reduction were sustained throughout the 52 weeks of treatment. Patients who transitioned from placebo to bremelanotide in the open-label phase showed improvements similar to those observed in the controlled trials.

A particularly relevant finding was the average frequency of medication use, which was around 1.5 doses per month, indicating that patients used the treatment as needed and did not develop a pattern of excessive use. The on-demand subcutaneous self-administration profile was well accepted by patients.

This study provided the long-term safety data necessary for regulatory approval and offers confidence for healthcare professionals and patients regarding the continued use of bremelanotide in the management of HSDD.