Drug for sexual desire disorder in women also works for men

SAN ANTONIO – A drug approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal women also improved sexual dysfunction in some men, according to a small data set published here.

Of 19 men with sexual dysfunction, 70% or more reported subjective improvement in multiple aspects of sexual arousal and activity with the dopamine modulator bremelanotide (Vyleesi). More men than women filled prescriptions for the drug during follow-up for up to four years, suggesting the drug was helpful in men with sexual dysfunction.

Notable side effects included nausea, often treated concurrently with ondansetron, and spontaneous erections without sexual stimulation, sometimes lasting intermittently for up to 24 hours, Irwin Goldstein, MD, of San Diego Sexual Medicine, reported at the annual meeting of the American Urological Association .

“It was an observational study in our clinic with a lot of people using it, and it proved to be helpful,” Goldstein said. There are already symptomatic treatments for men with sexual dysfunction that work in part by maximizing smooth muscle relaxation or by high-level muscle relaxation that have a peripheral mode of action.

“The cool thing about (bremelanotide), and it definitely needs more study, is how it works in the CNS (central nervous system). “We now theoretically have the ability to treat men with different strategies, the central nervous system and the peripheral nervous system,” he noted.

Goldstein’s wife and director of clinical research, Sue V. Goldstein, added that the treatment often resulted in multiple positive effects.

“We would ask a man to describe his sexual dysfunction and it could be an orgasm problem, which is a fairly common reason for the prescription,” she said. “We asked if the medication relieved the orgasm problem and they said yes. We asked if it helped with erections and they said yes.”

“We might have prescribed it for one type of sexual dysfunction, but it actually helped across the spectrum. That’s what intrigued me the most,” she added.

An unidentified member of the audience noted that the drug is an analogue of α-melanocyte-stimulating hormone with an affinity for the melanocortin-4 receptor and wondered if men might have more receptors than women, what Bremelanotide could potentially make it more effective in men.

“I have no idea, but it’s a great opportunity to study it,” Goldstein said.

In response to another question, Goldstein said most men had already tried conventional treatments without success, but many continued their existing treatment along with subcutaneous bremelanotide injections.

Another unidentified listener said he had been prescribing bremelanotide for several years and that some patients had had better results by changing the treatment plan. Instead of giving the drug at bedtime, they inject it 8 or 10 hours earlier in the day.

The FDA approved bremelanotide for premenopausal women with HSDD in June 2019. The drug modulates dopaminergic signaling pathways involved in sexual desire and arousal. Studies in women and men showed that the drug increases genital blood flow within hours of subcutaneous administration.

Shortly after bremelanotide was approved, Goldstein began prescribing the drug off-label to postmenopausal women and men with various forms of sexual dysfunction, as well as to premenopausal women. To better understand the use of bremelanotide in men and evaluate the drug’s clinical effects, the Goldsteins analyzed prescription bremelanotide dispensing data for September 2019 through June 2023. They also studied men who were prescribed bremelanotide for sexual dysfunction starting in May 2021 was.

A subgroup of men completed a questionnaire that collected information about sexual health, quality of life, overall impression of improvement in sexual dysfunction, and general health status. The men also agreed to a structured telephone interview.

In the 46 months beginning September 2019, bremelanotide was prescribed 444 times for male sexual dysfunction, 104 times in postmenopausal women, and 76 times in premenopausal women. Refill rates were 65% in men, approximately 50% in postmenopausal women, and 40% in premenopausal women. For the 18-month period beginning May 2021, refill rates were 73% in men, 50% in postmenopausal women, and about 45% in premenopausal women.

Of 21 men who agreed to the study, 19 completed the online questionnaire. More than 90% reported that insertion into the vagina during intercourse was easier; About 80% or more reported an improvement in their partner’s sexual experience, the quality of lovemaking, an expectation that lovemaking would be more enjoyable and carefree, greater ease in initiating lovemaking, and satisfaction with lovemaking and its duration; and about 70% or more found lovemaking more pleasurable and orgasm more pleasurable and reported that they orgasmed more easily.

The most commonly reported adverse reactions associated with bremelanotide were flushing (36%), nausea (36%), headache (27%), bothersome spontaneous erections (27%), incontinence (9%) and abdominal burning (9%). All adverse events were transient in nature.

“Some men have had erections that lasted a day and panicked about priapism, but to the best of our knowledge they had no erection problems after that prolonged erection,” Goldstein said.

Sue Goldstein pointed out that the erections did not last for 24 hours, but rather lasted for a period of time, followed by a period of no erection and then another period of spontaneous erection.