Safety Profile of Bremelanotide Across the Clinical Development Program
Clayton AH, Kingsberg SA, Portman D, et al. Journal of Women's Health 2022;31:171-182.
What it found
Across 43 studies and about 3,500 participants, the most common side effects in the double-blind phase 3 trials were nausea (40.0% vs 1.3% on placebo), flushing (20.3% vs 1.3%), headache (11.3% vs 1.9%) and injection site reactions (5.4% vs 0.5%). Focal skin darkening was rare at labelled use but affected more than a third of people given up to 16 daily doses. Small, short-lived blood pressure rises were seen. It lowered blood levels of indomethacin and naltrexone.
Limitations
Pooled review of the developer's own programme, written by authors linked to the developers. 70% of the bremelanotide group continued to the open-label phase versus 87% on placebo.
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