Bremelanotide and flibanserin for low sexual desir... - PT-141 Study

Key Findings

Flibanserin (Addyi) approved in 2015, bremelanotide (Vyleesi) approved in 2019

Clinical trials showed flibanserin adds ~1 enjoyable sexual experience per 2 months; bremelanotide showed no meaningful increase

Regulatory approvals may have been swayed by industry advocacy and conflicted testimony

Practical Outcomes

These drugs are unlikely to provide noticeable improvements in sexual desire for most users, so biohackers should be cautious about spending on them and may want to focus on other evidence‑based strategies.

Summary

The paper says the two FDA‑approved drugs for low sexual desire in women – flibanserin and bremelanotide – barely work, with flibanserin giving only about one extra enjoyable sex event every two months and bremelanotide showing no real benefit.

Abstract

The US Food and Drug Administration (FDA) has approved two drugs for 'hypoactive sexual desire disorder' in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy campaign and conflicted patient and expert testimony likely influenced flibanserin's approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.

Study Information

Provider

pubmed

Year

2021

Date

2021-10-12T00:00:00.000Z

DOI

10.1136/dtb.2021.000020

Citations

References