Bremelanotide (formerly PT-141)
Bremelanotide is Palatin’s novel drug candidate for the treatment of male and female sexual dysfunction. First in a new class of therapies called melanocortin agonists, bremelanotide has shown promise in effectively treating erectile dysfunction (ED) without the cardiovascular effects found in ED drugs currently available. Bremelanotide works through a mechanism of action involving the central nervous system rather than directly on the vascular system. As a result, it may offer significant safety and efficacy benefits over currently available products. To date, bremelanotide has shown positive results in four Phase 2 efficacy studies enrolling more than 1,300 men. Plans for Phase 3 clinical studies have been delayed pending review of U.S. Food and Drug Administration concerns about the acceptable benefit/risk ratio to support progression of the program into Phase 3. Palatin has also conducted a Phase 1 study in 32 premenopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A Phase 2A pilot clinical study evaluating Bremelanotide in pre-menopausal women diagnosed with female sexual dysfunction (FSD) has shown encouraging results.