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.1 Approximately 5.8 million pre-menopausal women have a primary diagnosis of HSDD.2,3,4 Recent market research indicates that 95 percent of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition.4 Furthermore, the majority of these women indicated a willingness to try a product like Rekynda, if recommended by their doctor.4
“We are pleased about the potential to further serve the health needs of women with the addition of Rekynda to AMAG’s expanding portfolio,” said
About RekyndaTM (bremelanotide)
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% 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.
Rekynda has no known alcohol interactions.
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 and families we serve. Our products support the health of patients in the areas of maternal health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: Rekynda’s strategic fit for AMAG’s women’s health business; the breadth of the FSD and HSDD markets and Rekynda’s market potential; AMAG’s ability to drive awareness and understanding of HSDD; the structure of planned and pending Rekynda clinical trials; and the expected timeline for clinical development and commercialization of Rekynda, including the timing for the new drug application (NDA), subsequent regulatory action by the
Such risks and uncertainties include: (1) uncertainties regarding AMAG’s and Palatin’s ability to successfully and timely complete clinical development programs and obtain regulatory approval for Rekynda in
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® is a registered trademark of
2 U.S. Census Bureau, 2015
3 Mayo Clinic Proceedings: “Hypoactive Sexual Desire Disorder: International Society for the Study of Women's Sexual Health (ISSWSH) Expert Consensus Panel Review,” Volume 92, Issue 1,
4 Burke Institute: Patient and Economic Flow Study,
CONTACTS: Investors for AMAG:
Linda LennoxVice President, Investor Relations 908-627-3424 Media for AMAG: Katie PayneVice President, External Affairs 202-669-6786