Another novel drug for female hypoactive sexual desire shows promising results in phase III trials.

Women who are distressed because of hypoactive sexual desire could soon find relief because of a new drug, Bremelanotide (BMT).

Female Sexual Dysfunctions (FSD) encompasses multifactorial entities affecting about 10% of the population. Few treatment options exist to treat this condition.

auto-injector for Bremelanotide, Palatine Technologies

Bremelanotide, is a novel cyclic 7-amino acid melanocortin-receptor agonist with a high affinity for the type-4 receptor. It increases levels of dopamine and norepinephrine in medial preoptic area, thereby,  modulating the  brain pathways involved in sexual response.

The results of two phase III trials were presented as a poster at the American Society of Clinical Psychopharmacology (ASCP) annual meeting, Florida May 29 – June 2, 2017.

The RECONNECT study comprises 2 Phase 3, multicenter trials involving 1,247 premenopausal women with low sexual desire. The women were in stable, monogamous relationship.

In this intent to treat study, the women underwent a month screening period and a month of treatment with a placebo so that the investigators could have an idea about various baseline scores.

Women were randomized to nearly 6 months of treatment with either self-administered BMT (1.75 mg) or placebo subcutaneously using an auto-injector, as-desired, prior to sexual activity. This was followed by an open label 52 weeks extension.

The control and cases were assessed on various indices like the desire domain of the Female Sexual Function Index (FSFI-D) and the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) score for feeling bothered by low sexual desire; FSDS total and bother scores; Women’s Index of Treatment Satisfaction (WITS-9) score; self-assessment of benefit, and satisfying sexual event (SSE) items of the Female Sexual Encounter Profile-Revised (FSEP-R).

Besides significantly improving the scores of all the indices, the women on BMT showed a significant improvement in number of satisfying sexual events, arousal, lubrication and orgasm. The women also reported feeling less distressed and more satisfied with their sexual relations.

Most common side effects encountered were nausea, vomiting, flushing, or headaches resulting in 18% of women to discontinue the drug as compared to 2% in placebo group.

The average age of the study participants was 39 years, more than 80% were white with a mean BMI of 28.7 kg/m2 and most of them were suffering from hypoactive sexual desire disorder (HSDD) with decreased arousal.

In 2015, FDA approved the little pink pill or flibanserin (Addyi) a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, as the first treatment for hypoactive sexual desire disorder in premenopausal women.

The authors concluded, “Treatment with BMT is associated with clinically meaningful and statistically significant improvement in desire and a decrease in distress; both hallmark characteristics of HSDD. BMT is an efficacious treatment for key aspects of sexual function — desire, arousal, lubrication, and orgasm, in premenopausal women.”

All the poster abstracts at the conference can be accessed here.