Study summary · research use only
Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This review (human; phase 2 and phase 3 trial literature review) examined data on bremelanotide, a melanocortin 4 receptor agonist injection approved for hypoactive sexual desire disorder (HSDD), searching literature from January 1, 1996 to December 15, 2019, and including 2 reports of phase 3 trials and 2 reports of phase 2 trials. The abstract reports that bremelanotide was associated with improvement in desire and a decrease in distress related to lack of desire, with the most common adverse effects being nausea (39.9%), facial flushing (20.4%), and headache (11%). Guidance described in the abstract calls for administration about 45 minutes before sexual activity, no more than 1 dose in 24 hours, no more than 8 doses per month, and discontinuation after 8 weeks without benefit.
Abstract
Objective: To review data regarding bremelanotide, a recently approved therapy for hypoactive sexual desire disorder (HSDD). Data Sources: Literature search of Medline, SCOPUS, and EMBASE was performed using the search terms bremelanotide, bremelanotide injection, Vyleesi, and melanocortin 4 receptor agonist between January 1, 1996, and December 15, 2019. Reference lists from included articles were also reviewed for pertinent citations. Study Selection/Data Extraction: We included phase 2 and 3 trials of bremelanotide. There were 2 reports of phase 3 trials and 2 reports of phase 2 trials. Additional information from supplementary analyses was also referenced. Data Synthesis: Bremelanotide demonstrates significant improvement in desire and a significant decrease in distress related to lack of desire. The most common adverse effects include nausea (39.9%), facial flushing (20.4%), and headache (11%). Relevance to Patient Care and Clinical Practice: Bremelanotide is the second Food and Drug Administration-approved medication for the treatment of HSDD. Bremelanotide's place in therapy is unknown, as the HSDD guidelines were last updated in 2017. Although the trials met statistical significance for change in sexual desire elements and distress related to sexual desire, the clinical benefit may only be modest. Conclusion: Bremelanotide is a subcutaneous injection that can be administered as needed approximately 45 minutes prior to sexual activity. Bremelanotide is safe and has limited drug-drug interactions, including no clinically significant interactions with ethanol. Prescribing guidelines recommend no more than 1 dose in 24 hours and no more than 8 doses per month. Individuals should discontinue use after 8 weeks without benefit.
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