Biopharmaceutical company Palatin Technologies has announced that its Phase IIb bremelanotide female sexual dysfunction (FSD) trial met the primary endpoint and key secondary endpoints.
The multi-centred, randomised, placebo-controlled study, which enrolled around 400 premenopausal women, was designed to assess the efficacy and safety of bremelanotide in treating FSD.
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Palatin president and CEO Dr Carl Spana said the trial achieved statistical significance in the 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 III trials and activities,” Spana said.
The study demonstrated a statistically significant increase in the number of satisfying sexual events, improved measures of overall sexual function and a reduction in distress related to sexual dysfunction in bremelanotide group, compared with placebo.
The primary endpoint and key secondary endpoints were measured from the results observed during the last four weeks of treatmen,t compared to the reported results during the baseline period.
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By GlobalDataData analysis of the individual 0.75mg, 1.25mg and 1.75mg bremelanotide doses demonstrated clinically meaningful improvement for the primary endpoint and key secondary endpoints while the 1.75mg dose achieved statistical significance for the endpoints.
Palatin chief medical officer Dr Jeff Edelson said the data demonstrates the safety and efficacy of bremelanotide and suggest its potential utility for the treatment of FSD in premenopausal women.
“Moreover, the trial provides important data that will be instrumental in planning Phase III clinical trials and activities. We look forward to working closely with our expert advisors, and the FDA, to identify next steps in the late stage clinical development of this exciting drug,” Edelson said.
Bremelanotide was well-tolerated in the trial in which facial flushing, nausea and emesis (vomiting) were the most common adverse events reported.
