Bremelanotide for Female Sexual Dysfunction
Palatin Technologies is developing bremelanotide as a subcutaneous product intended for female sexual dysfunction (FSD). Ongoing Phase 2B clinical trials are testing bremelanotide in premenopausal women with FSD.
Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
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.
The ongoing Phase 2B is a sixteen week, dose ranging “at home” placebo controlled study. Three different active doses are being evaluated in the study. Target enrollment is 400 premenopausal FSD patients, with data from the study expected in the second half of calendar 2012. The study addresses endpoints of increases in satisfying sexual events, improvements in arousal and desire and decrease in sexual distress. For more information on this clinical trial with bremelanotide, please visit www.clinicaltrials.gov.
We extensively studied bremelanotide for sexual dysfunction in nasal formulations, administered as a single spray in one nostril. Increases in blood pressure were observed in some patients receiving nasally administered bremelanotide, and this observed increase was a significant factor leading us to discontinue work on nasally administered bremelanotide as a first-line therapy for sexual dysfunction. We believe that with subcutaneous administration exposure to bremelanotide is tightly controlled, limiting exposures to levels associated with increases in blood pressure and other adverse events.
Palatin Technologies has extensive clinical experience with bremelanotide. Over 2,000 patients have received bremelanotide in 30 clinical studies with either intranasal or subcutaneous formulations, with demonstrated efficacy for both FSD and erectile dysfunction.
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