Palatin has announced positive top-line results from the Phase 3 clinical trial of bremelanotide (a melanocortin 4 receptor agonist), an investigational treatment for hypoactive sexual desire disorder (HSDD).
The Reconnect Studies consist of two randomized, double-blinded, placebo-controlled Phase 3 studies, comparing the efficacy and safety of bremelanotide versus placebo in premenopausal women diagnosed with HSDD. The modified intent-to-treat patient group included a total of 1,202 women with HSDD in the U.S. and Canada.
Johna D. Lucas, MD, Chief Medical Officer of Palatin, said, “In Phase 3 trials bremelanotide was used as needed by premenopausal women with HSDD, with a single dose self-administered in anticipation of sexual activity.
The co-primary endpoints were improvements in the Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13, while satisfying sexual events is a secondary endpoint.
Results from the two studies showed a statistically significant increase in FSFI-D score for the bremelanotide vs. placebo group (Study 301: mean change of 0.54 vs. 0.24, median change of 0.60 vs. 0.00; P=0.0002; Study 302: mean change of 0.63 vs. 0.21, median change of 0.60 vs. 0.00; P=0.0001).
For FSDS-DAO Item 13, a significant reduction in distress related to low sexual desire was associated with the bremelanotide group compared to the placebo group (Study 301: mean change of -0.74 vs. 0.35, median change of -1.0 vs. 0.00; P=0.0001; Study 302: mean change of -0.71 vs. -0.41, median change of -1.0 vs. 0.00; P=0.0057). The co-primary endpoints were decided after discussions with the Food and Drug Administration (FDA).
“Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis,” said Carl Spana, PhD, President and Chief Executive Officer of Palatin.
The company is aiming to file a New Drug Application (NDA) for bremelanotide with the FDA in the second half of 2017.