This record provides bibliographic details and links to the original research. An editorial study breakdown is not available.
What the researchers found
Flibanserin added ~0.5 satisfying sexual events/month; bremelanotide added none by primary outcome. Both approvals involved shifted endpoints and contested indications.
Why it matters
Regulatory decisions based on weak evidence can set precedents that lower the bar for future drug approvals.
The numbers in context
Flibanserin: +0.5 SSE/month; bremelanotide: no primary endpoint benefit; flibanserin approved on 3rd attempt; shifted primary outcomes
How the study worked
Critical regulatory analysis of clinical trial data, endpoint shifts, advocacy campaigns, and approval processes for flibanserin and bremelanotide.
Who was studied
Premenopausal women with hypoactive sexual desire disorder (from Phase III trials)
What this study cannot tell us
Critical analysis from one perspective. Drug regulators and manufacturers may disagree. Patient-reported outcomes like desire are inherently subjective.
Read the original research
Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.
Drug and therapeutics bulletin, 59(12), 185-188
Citation
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