Bremelanotide official document review · version 1
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Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
Desire and distress were the supported outcomes
FDA’s 2019 review describes two six-month placebo-controlled trials in premenopausal women with acquired, generalized hypoactive sexual desire disorder. The supported outcomes were modest improvements in reported desire and associated distress. FDA PDF pp. 22, 26 ↗
More findings, study links and document coverage
A related endpoint did not improve
Bremelanotide did not improve the number of satisfying sexual events, a key secondary endpoint. FDA explained why improvement on that measure was not required for this specific indication. FDA PDF pp. 26 ↗
The measurement window affects interpretation
The questionnaires recalled approximately a month, while use in the trials was intermittent. FDA discussed this mismatch when interpreting patient-reported changes; the scores should not be presented as a response to every individual use. FDA PDF pp. 26 ↗
The studied population limits the conclusion
FDA did not establish efficacy in postmenopausal women in this review. Blood-pressure effects, nausea and pigmentation changes were important safety issues, and limited pregnancy information led to further study requirements. FDA PDF pp. 23, 26 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Vyleesi: FDA selected application review ↗
Selected sections reviewed · fda-bremelanotide-review-2019 · Document/feed date: 2019-06-21
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Vyleesi · NDA 210557 · Document dated 2019-06-21. Identity checked on PDF pp. 5.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 5, 22, 23, 26 of 539. SHA-256:
065ab49b8fbc93c5bbdcff0604d966f2256f177e644b01b82b169a1e74e0e564.
Remaining work
- Review the pivotal publications, discontinuation patterns and later postmarketing requirements.
- Reconcile subsequent labeling and pregnancy follow-up without treating the 2019 review as current surveillance.