Bremelanotide for Female Sexual Dysfunction
Palatin Technologies is developing bremelanotide for female sexual dysfunction, or FSD. Bremelanotide is in Phase 3 clinical trials; to find out more about Palatin's current bremelanotide trials or if the studies are enrolling patients in your area, please visit www.clinicaltrials.gov, www.reconnectstudy.com or email firstname.lastname@example.org.
We are developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH. The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual arousal response.
We have completed a Phase 2B clinical trial and meetings with the U.S. Food and Drug Administration (FDA), and started patient enrollment in the Phase 3 clinical trials in December 2014. The Phase 3 studies, which will be conducted in North America, will utilize a single-dose autoinjector intended for commercialization. It is anticipated that the Phase 3 program will take at least fifteen to eighteen months from initiation of patient dosing through database lock. Following database lock, clinical trial data will be analyzed and, assuming the data supports approval of bremelanotide for FSD, a New Drug Application (NDA) will be submitted to FDA.
In the recently completed Phase 2B clinical trial, bremelanotide 1.25 mg and 1.75 mg doses significantly increased sexual arousal, sexual desire and the number of sexually satisfying events, and decreased associated distress in premenopausal women with FSD. Efficacy was seen in both women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD).
In the Phase 2B trial, bremelanotide showed a statistically significant increase in the number of satisfying sexual events (SSEs) versus placebo (mean increase in SSEs of 0.8 (2.9) for 1.75 mg (p = 0.0215) and 0.7 (2.4) for 1.25/1.75 mg pooled (p = 0.0180) versus 0.2 (2.3) for placebo).
FSD is a multifactorial condition that has anatomical, physiological, medical, psychological and social components. FSD includes four disorders, hypoactive sexual desire disorder, female sexual arousal disorder, sexual pain disorder and orgasmic disorder. To establish a diagnosis of FSD, these syndromes must be associated with personal distress, as determined by the affected women. Approximately 40 million American women are affected by FSD. The National Health and Social Life Survey, a probability sample study of sexual behavior in a demographically representative cohort of United States adults ages 18 to 59, found that approximately 43% of women suffer from some form of FSD. There are no Food and Drug Administration approved drugs for FSD.
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. The study dosed 394 patients. A total of 26 patients discontinued based on predefined blood pressure criteria; these patients were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 patients discontinued from the study due to adverse events (placebo 2, bremelanotide 10). Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributed to bremelanotide during the trial.
Palatin Technologies has extensive clinical experience with bremelanotide. Over 2,500 patients have received bremelanotide in 30 clinical studies with either intranasal or subcutaneous formulations, with demonstrated efficacy for both FSD and erectile dysfunction.