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news.Palatin Technologies has reported positive results from an at-home Phase II trial evaluating bremelanotide for the treatment of female sexual arousal disorder. The objective of the trial was to identify potential efficacy endpoints for future studies and to evaluate the safety of intranasal bremelanotide, relative to placebo and under the conditions of home use, for the treatment of FSAD in pre- and postmenopausal women.
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Trevor Hallam, executive vice president of R&D for Palatin, said: “We are pleased with the overall data from this exploratory trial. The efficacy response was consistent and robust across all domains, particularly desire and arousal. We look forward to discussing the program’s further development with the FDA, including future dose-ranging studies to improve the drug’s benefit/risk profile.”
The trial was double-blinded, placebo-controlled and enrolled 76 premenopausal and 87 postmenopausal women who were followed for one month to determine their baseline level of sexual dysfunction. The patients were then randomized to receive IN doses of either placebo or 10 mg of bremelanotide. Changes in their level of sexual function were assessed over a two month period using the female sexual encounter profile (FSEP), the female sexual function index (FSFI) and the female sexual distress score (FSDS). The first dose was given in the clinic. Prespecified changes in blood pressure, as well as emesis, led to mandatory discontinuation. All endpoints were exploratory without preset statistical goals.
In the intention-to-treat population, the bremelanotide treated postmenopausal women showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. In these patients, the FSFI domains of arousal, desire and orgasm were statistically significantly improved compared to placebo at one month. The arousal and orgasm domains were statistically significantly improved compared to placebo at one and two months.
In the intention-to-treat population, the bremelanotide treated premenopausal women showed statistically significant improvements, compared to baseline, in desire and arousal success rates, and overall satisfaction at one and two months. However, while there was a consistent trend to greater improvement in these measures in bremelanotide patients compared to placebo treated patients, the differences were not statistically significant between bremelanotide and placebo treated patients because the placebo responses were themselves statistically significantly improved compared to baseline.
Eileen Palace, The Center for Sexual Health, Metairie, LA, said: “With no approved medical therapies to treat patients with FSAD, I believe the results of the clinical trials with bremelanotide warrant further development.”