CRANBURY, N.J., Feb. 24, 2014 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) presented new analyses from its Phase 2b clinical trial of bremelanotide, which demonstrated dose-dependent improvements in sexual desire and treatment satisfaction in premenopausal women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD), both which are forms of female sexual dysfunction (FSD). 1,2,3
The data from three clinical abstracts were presented Saturday, February 22, 2014 at the International Society for the Study of Women's Sexual Health (ISSWSH) conference in San Diego. Bremelanotide is a first-in-class, investigative melanocortin agonist being developed for treatment of female sexual dysfunction (FSD).
"We are excited by the potential that bremelanotide may offer women in treating HSDD, a condition that has been recognized for more than 30 years but for which there is no FDA-approved therapy," said Carl Spana, Ph.D., President and CEO of Palatin. "Unlike other investigational therapies in development for FSD, bremelanotide is an on-demand medication that has been shown to work within 30 to 60 minutes of administration. That would allow women to take it when they need it, providing them with a quick response, greater control and flexibility in their treatment."
In one abstract, responder analyses showed bremelanotide had a statistically significant increase in the percentage of women whose total score on the Female Sexual Function Index (FSFI) – a measure of overall sexual functioning – improved: 69% for 1.75 mg versus 46% for placebo (p<0.05). 1 In addition, a significantly higher percentage of women on bremelanotide versus placebo achieved at least one satisfying sexual event (SSE): 55% for 1.75 mg versus 37% for placebo (p<0.05). 1A second abstract, presenting data from the episodic questionnaire, Female Sexual Encounter Profile – Revised (FSEP-R), demonstrated greater mean increases in SSEs within 24 hours of dosing with bremelanotide 1.75 mg (mean increase: 0.7; p=0.0443) versus placebo (mean increase: 0.1). As-needed administration of bremelanotide 1.75 mg versus placebo also demonstrated episodic increases in levels of desire (0.4 vs. 0.0, respectively) and in the women's satisfaction with their levels of desire (0.6 vs. 0.1, respectively). 2 In a third abstract, data collected from the Women's Inventory of Treatment Satisfaction (WITS-9) showed women who completed treatment were significantly more satisfied with bremelanotide 1.75 mg (0.77; p=0.0204) versus placebo (0.17). 3 "Additional analyses continue to yield robust, positive data for bremelanotide, which shows promise in addressing an important unmet need for women living with HSDD," said David J. Portman, MD, Principal Investigator at the Columbus Center for Women's Health Research, and in private practice with Portman Obstetrics and Gynecology. "The findings from these abstracts show that bremelanotide can significantly improve desire and sexual functioning. More importantly, women were satisfied with treatment, which is a predictor not just of satisfaction but with compliance and the continuation of treatment." Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 394 patients. Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributed to bremelanotide during the trial.