Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder — RECONNECT Phase III Trials — VialBase Research
Bremelanotide 1.75mg SC significantly increased sexual desire vs placebo
- Bremelanotide 1.75mg SC significantly increased sexual desire vs placebo
- Significantly reduced sexually related personal distress
- Measured by Female Sexual Distress Scale and Female Sexual Function Index
- Two pivotal Phase III trials (RECONNECT) in premenopausal women with HSDD
- Led to FDA approval of Vyleesi in June 2019
- Most common adverse event was nausea (~40%)
Summary
Two pivotal Phase III, randomized, double-blind, placebo-controlled trials (RECONNECT) evaluating bremelanotide 1.75mg subcutaneous injection for premenopausal women with hypoactive sexual desire disorder (HSDD). These are the registration trials that led to FDA approval of Vyleesi in June 2019.
Key Findings
- Bremelanotide 1.75mg SC significantly improved sexual desire compared to placebo
- Significant reduction in sexually related personal distress (Female Sexual Distress Scale)
- Improvement in sexual function (Female Sexual Function Index)
- On-demand dosing (45 min before anticipated activity) was effective
- Nausea was the most common adverse event (~40%), usually mild-moderate and diminishing with use
- Transient blood pressure elevation noted but clinically manageable
- Favorable benefit-risk profile leading to FDA approval
Relevance to PT-141
This is the pivotal clinical dataset behind PT-141’s FDA approval — the highest level of evidence for any peptide in the sexual health category. The RECONNECT trials establish bremelanotide as the first (and only) on-demand, non-hormonal treatment for HSDD. The 40% nausea rate is the primary tolerability concern that clinicians and patients need to weigh against efficacy.
Citation
Kingsberg SA, et al. Obstet Gynecol. 2019;134(5):899-908. PMID: 30599891
See Also
- Parent compound: PT-141