New Agent for Female Sexual Dysfunction Has Promise
CHICAGO -- The melanocortin-receptor-4-agonist bremelanotide appeared to reduce distress and increase satisfaction among premenopausal women with female sexual dysfunction, researchers reported here.
In phase II studies, a 1.75-mg subcutaneous dose of the experimental bremelanotide lead to a mean reduction of about 1.1 points in Female Sexual Distress Scale-Desire/Arousal/Orgasm score compared with a mean reduction of about 0.6 points among placebo patients (P<0.001), said Sheryl Kingsberg, PhD, from Case Western Reserve University in Cleveland, and colleagues.
Combining the 1.25-mg dose and the 1.75-mg dose, the reduction was about 0.9 points (P<0.01 versus placebo), Kingsberg sad at a poster presentation at the American College of Obstetricians and Gynecologistsannual meeting.
"There are no approved drugs for hypoactive sexual desire disorder in women," she told MedPage Today.
"Female sexual dysfunction is a class of disorders that constitute the most prominent sexual disorders in women," she went on to explain. "You could still have sex and it would be pleasurable, but it is about wanting sex."
In a companion study that specifically looked at hypoactive sexual desire disorder, David Portman, MD, director of the Columbus Center for Women's Health Research in Ohio, said that treatment with bremelanotide resulted in women boosting the number of satisfactory sexual events in a month.
The study by Kingsberg's group focused on the evaluation of how at-home, self-administered bremelanotide relieved the stress attached to hypoactive sexual desire.
"The FDA requires that the treatment reduce stress on the Female Sexual Distress Scale-Desire/Arousal/Orgasm," Kingsberg said. "We demonstrated a dose-dependent efficacy for bremelanotide to reduce the distress of feeling bothered by low sexual desire."
The 12-week study had 97 women who were randomized to received placebo, 87 women who were treated with a 0.75 mg dose of bremelanotide, which was a dose that was not more effective than placebo, 75 women who were treated with 1.25 mg of bremelanotide, and 74 women on a high dose of 1.75 mg. The women self-administered the drug on an as-needed basis.
Responder rates for satisfying sexual events were 37% for placebo, 38% for 0.75-mg dose, 48% for 1.25-mg dose, 55% for 1.75-mg dose, and 51% for 1.25-mg and 1.75-mg pooled dose. Responder rates were 45%, 49%, 60%, 69%, and 64%, respectively, on the Female Sexual Distress Scale-Desire/Arousal/Orgasm.
Patients taking bremelanotide reported more nausea, flushing, and headaches than those on placebo. About 5% of the placebo patients and 10% of the 1.75-mg dose of bremelanotide patients withdrew from the study because of adverse events, but the drug was generally well tolerated, Kingsberg said.
"Bremelanotide has finished its phase II studies and designs for phase III are now awaiting approval from the FDA," she said.
In the phase IIB, 24-week study by Portman's group, women self-administered the drug about 45 minutes prior to anticipated sexual activity. Of the 327 participants, the majority had either mixed hypoactive sexual desire disorder and female sexual arousal disorder with a primary diagnosis of hypoactive sexual desire disorder.
The mean change in sexual satisfying events with was increased by 0.3 events per month among the 76 placebo patients; by 0.7 events a month among the 62 women assigned to the 1.75-mg dose (P<0.05); and by 0.7 events per month in the 128 patients in the pooled 1.25-mg and 1.75-mg dose (P<0.05).
"In premenopausal hypoactive sexual desire disorder, subcutaneous bremelanotide yielded improvements across all key hypoactive sexual desire disorder measures with robust dose-dependence attaining statistical significance at 1.75 mg," the authors concluded.
The studies were funded by Palatin Technologies.
Kingsberg disclosed relevant relationships with Palatin Technologies, Sprout Pharmaceuticals, BioSante, Novo Nordisk, Shionogi, Apricus, Emotional Brain, Pfizer, Trimel Pharmaceuticals, and Viveve.
Portman disclosed relevant relationships with Palatin Technologies, Apricus Bioscience, Bayer, Pfizer, Shionogi, and Sprout Pharmaceuticals.
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