Palatin Presents Positive Data Analyses From Phase 2b Trial Of Bremelanotide

(RTTNews) - Palatin Technologies Inc. (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 or HSDD and combined HSDD/female sexual arousal disorder or FSAD, both which are forms of female sexual dysfunction or FSD.

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). In addition, a significantly higher percentage of women on bremelanotide versus placebo achieved at least one satisfying sexual event or SSE: 55% for 1.75 mg versus 37% for placebo (p<0.05).

A 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).

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).

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.

Palatin anticipates commencing enrolling patients in Phase 3 clinical trials in the second half of this year.