AMAG Pharmaceuticals has announced licensing agreement with Palatin Technologies, for exclusive North American commercial rights to Rekynda (bremelanotide), an investigational product developed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The agreement will help AMAG Pharmaceuticals to strengthen its presence in women’s health.
HSDD, the most common type of female sexual dysfunction (FSD), affects approximately 15 million women in the U.S. and is characterized by low sexual desire that causes marked distress or interpersonal difficulties. Approximately 5.8 million pre-menopausal women have a primary diagnosis of HSDD. Recent market research indicates that 95 percent of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition. Furthermore, the majority of these women indicated a willingness to try a product like Rekynda, if recommended by their doctor.
Palatin has successfully completed two phase 3 clinical trials for Rekynda, with co-primary endpoints met. AMAG expects to file an NDA for Rekynda in early 2018, with an anticipated approval and launch by early 2019.
Rekynda (bremelanotide), an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
The two phase 3 studies for HSDD in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg of Rekynda delivered via an auto-injector pen to placebo. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, Rekynda met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.
Women in the trials had the option, after completion of the trial, to continue in an ongoing open-label safety extension study for an additional 12 months. Nearly 80 per cent of patients elected to remain in the open-label portion of the study, and all of these patients will continue to receive Rekynda.
In both phase 2 and phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in severity.
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients.