Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.
Quick Facts
What This Study Found
Flibanserin added ~0.5 satisfying sexual events/month; bremelanotide added none by primary outcome. Both approvals involved shifted endpoints and contested indications.
Key Numbers
Flibanserin: +0.5 SSE/month; bremelanotide: no primary endpoint benefit; flibanserin approved on 3rd attempt; shifted primary outcomes
How They Did This
Critical regulatory analysis of clinical trial data, endpoint shifts, advocacy campaigns, and approval processes for flibanserin and bremelanotide.
Why This Research Matters
Regulatory decisions based on weak evidence can set precedents that lower the bar for future drug approvals.
What This Study Doesn't Tell Us
Critical analysis from one perspective. Drug regulators and manufacturers may disagree. Patient-reported outcomes like desire are inherently subjective.
Trust & Context
- Original Title:
- Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.
- Published In:
- Drug and therapeutics bulletin, 59(12), 185-188 (2021)
- Authors:
- Mintzes, Barbara, Tiefer, Leonore, Cosgrove, Lisa
- Database ID:
- RPEP-05614
Evidence Hierarchy
Summarizes existing research on a topic.
What do these levels mean? →Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-05614APA
Mintzes, Barbara; Tiefer, Leonore; Cosgrove, Lisa. (2021). Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.. Drug and therapeutics bulletin, 59(12), 185-188. https://doi.org/10.1136/dtb.2021.000020
MLA
Mintzes, Barbara, et al. "Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.." Drug and therapeutics bulletin, 2021. https://doi.org/10.1136/dtb.2021.000020
RethinkPeptides
RethinkPeptides Research Database. "Bremelanotide and flibanserin for low sexual desire in women..." RPEP-05614. Retrieved from https://rethinkpeptides.com/research/mintzes-2021-bremelanotide-and-flibanserin-for
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.