Safety Profile of Bremelanotide Across the Clinical Development Program
Clayton AH, Kingsberg SA, Portman D, et al. (2022). Journal of Women's Health.
Summary
A pooled review of safety data across the drug's whole clinical development programme. In the double-blind portion of the phase 3 studies, nausea affected 40 percent of the bremelanotide group against 1 percent on placebo, flushing 20 percent, headache 11 percent, and injection-site reactions 5 percent. Nausea was the most common reason for stopping. No deaths occurred and serious adverse events were rare. Focal hyperpigmentation was rare at the labelled frequency of use but occurred in more than a third of participants given up to 16 consecutive daily doses. Small transient blood-pressure increases were seen, and the authors advise caution in people at cardiovascular risk. Written by investigators associated with the development programme.