Bremelanotide shows sustained improvement in sexual dysfunction in women, confirms study

USA: Premenopausal women treated with the novel drug bremelanotide showed sustained improvements in hypoactive sexual desire disorder symptoms, according to a recent study published in the Obstetrics & Gynecology journal. The results are based on two randomized, controlled trials and a 52-week open-label extension study.

Bremelanotide, an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone, received FDA approval for this indication in June 2019.

"Female sexual dysfunction comprises a group of sexual disorders related to desire, arousal, and interest, as well as orgasm. Hypoactive sexual desire disorder, defined as the persistent or recurrent deficiency or absence of sexual fantasies or thoughts and desire for—or receptivity to—sexual activity, is the most prevalent female sexual dysfunction associated with personal distress and is not explained by another mental disorder, medical condition, or medication," the authors wrote in the journal.

James A. Simon, George Washington University and IntimMedicine Specialists, Washington, and colleagues evaluate the long-term safety and efficacy of bremelanotide as treatment for hypoactive sexual desire disorder in premenopausal women.

The researchers performed two separate, identically designed phase 3 studies (RECONNECT). Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo.

The study 301 open-label extension began on July 17, 2015, and concluded on July 13, 2017; the study 302 open-label extension began on October 5, 2015, and concluded on June 29, 2017.

Key findings of the study include:

• Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24, compared with placebo.


• They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain.


• The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%).


• Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study consisted of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

DOI: 10.1097/AOG.0000000000003514

Journal Information: Obstetrics & Gynecology