Palatin Technologies, Inc. (NYSE MKT: PTN) today reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD).
The data demonstrate that women taking bremelanotide showed statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo.
The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, shows a clinically meaningful and statistically significant improvement (p=0.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50% increase in SSEs with bremelanotide versus 12% with placebo.
"We are extremely pleased to report the successful completion of this trial, which achieved statistical significance in our primary endpoint and key secondary endpoints using independently developed and validated measurement tools. Importantly, we met the objectives of the trial which demonstrated excellent safety and efficacy of the drug and identified doses for advancement into Phase 3 trials and activities" stated Carl Spana, Ph.D., President and CEO of Palatin. "Our next steps are to continue to compile and analyze additional data, to start the preparation process for an end-of-Phase 2 meeting with the FDA, and to further our discussions with potential collaboration partners."
In addition to meeting the primary endpoint, preliminary analysis of key secondary endpoints showed clinically meaningful and statistically significant improvement in patients who received bremelanotide vs. placebo (mean change from baseline to end of study; pooled 1.25 mg and 1.75 mg bremelanotide doses):
Improved overall sexual function, as measured by the Female Sexual Function Index (FSFI). The FSFI is a 19-item questionnaire which provides for an additional measurement of changes over a longer recall period.
FSFI total score improvement (mean change of 3.55 vs. 1.88, p=0.0017)
Reduction in distress related to sexual dysfunction, as measured by the Female Sexual Distress Scale-DAO (FSDS-DAO). The FSDS-DAO 15-item questionnaire is designed to assess and quantify the change in personal distress associated with female sexual dysfunction.
FSDS-DAO total score improvement (mean change of -11.1 vs. -6.8, p=0.036)
The primary endpoint and key secondary endpoints measurement period was defined as reported results during the last four weeks of treatment compared to the reported results during the baseline period. For all endpoints, the pre-specified statistical analysis as agreed to with the FDA was the pooled data for the 1.25 mg and 1.75 mg doses, compared to placebo.
Data analysis of the individual 0.75 mg, 1.25 mg and 1.75 mg bremelanotide doses each showed clinically meaningful improvement for the primary endpoint and key secondary endpoints, with the 1.75 mg dose achieving statistical significance for the endpoints cited above.