Vyleesi (Bremelanotide) Real-World Evidence: What Registries and Post-Market Data Show

What data exist beyond the trials?

Vyleesi was approved on June 21, 2019 (NDA 210557); the label is now held by Cosette Pharmaceuticals [2][4]. The 52-week extension ran from 2015 to 2017, before that approval, so it is not post-market data [1][2]. A PubMed search on bremelanotide with real-world, registry, claims, postmarketing, pharmacovigilance and retrospective terms (run October 30, 2026) returned no bremelanotide study other than this extension [5].

The label says there will be a pregnancy exposure registry monitoring outcomes in women exposed during pregnancy and lists (800) 922-1038 for reporting [2]. FDA's public adverse-event dashboard lets the public search reports submitted to FDA, and FDA states that a report does not mean the drug caused the event, that reports can be duplicated or incomplete, and that the data cannot be used to estimate incidence [3].

The 52-week open-label extension

Of 856 women who completed the double-blind phase, 684 enrolled in the extension and 272 completed it [1]. All analyses were descriptive and there was no placebo arm [1].

Drug-related treatment-emergent events were nausea in 40.4%, flushing in 20.6% and headache in 12.0%; the only severe event reported by more than one participant across both studies was nausea [1]. Because there was no placebo group, the extension cannot show how much of the observed change was due to Vyleesi [1].

The seven pregnancies in the label

Separately from the planned registry, the label reports 7 pregnancies during clinical trials involving more than 1,057 Vyleesi-treated patients, with no major congenital anomalies, one miscarriage, five full-term live births and one unknown outcome [2]. The label describes that number as too few to determine whether there is a drug-associated risk [2].

What the trial figures cover

The rate estimates still come from the placebo-controlled trials: nausea 40.0% vs 1.3%, flushing 20.3% vs 0.3%, injection-site reactions 13.2% vs 8.4%, headache 11.3% vs 1.9% [2]. Serious adverse reactions were reported in 1.1% vs 0.5%, and 18% vs 2% stopped treatment because of an adverse reaction [2]. Nausea was highest after the first dose, reported in 21%, and fell to about 3% with later doses; 8 mg of oral ondansetron taken 30 minutes before the injection did not reduce it in a phase 4 study of 228 healthy women [2].

Who the trials enrolled

The trial population had a mean age of 39 and was 86% White and 12% Black [2].