Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.
Level 1 - systematic review of randomized trials
Systematic review of phase 2 and phase 3 clinical trials
PubMed 31893927 · doi:10.1177/1060028019899152
What was done
A systematic review of literature from Medline, SCOPUS, and EMBASE (January 1, 1996, to December 15, 2019) evaluating bremelanotide for hypoactive sexual desire disorder (HSDD). The authors extracted data from 2 phase 3 trial reports and 2 phase 2 trial reports, along with supplementary analyses.
What was found
Bremelanotide demonstrated statistically significant improvements in sexual desire and reductions in distress related to lack of desire, though the authors note the clinical benefit may be modest. The most common adverse effects were nausea (39.9%), facial flushing (20.4%), and headache (11%). Absolute numerical change scores and confidence intervals for efficacy endpoints were not reported in the abstract.
Why it matters
As the second FDA-approved therapy for HSDD, as-needed subcutaneous bremelanotide offers an option with limited drug-drug interactions and no significant ethanol interaction, though clinicians must weigh modest clinical benefits against frequent nausea.
Limits
The abstract synthesizes only 4 trial reports and omits exact participant counts, baseline characteristics, and numerical efficacy outcome data (e.g., scale scores or effect sizes). Long-term adherence given high nausea rates and comparative effectiveness against other therapies were not detailed in the abstract.
Cited by
- supports PT-141 (Vyleesi / bremelanotide) is approved for hypoactive sexual desire disorder in women.