Both Phase 3 RECONNECT studies met co-primary endpoints and demonstrated significant improvement in key symptoms of hypoactive sexual desire disorder
WALTHAM, Mass. and CRANBURY, N.J.,
Both Phase 3 studies met their co-primary endpoints of improvements in desire (as measured by the Female Sexual Function Index – Desire domain (FSFI-D)) and decrease in associated distress (as measured by the Female Sexual Distress Scale – Desire/Arousal/Orgasm (FSDS-DAO)). These results were previously reported in
Multiple secondary endpoints were evaluated as part of the Phase 3 RECONNECT studies to provide a more comprehensive picture of Rekynda’s effect on different aspects and symptoms of sexual dysfunction. Rekynda was associated with statistically significant improvements in the total FSFI score including arousal, lubrication, orgasm, and satisfaction domain scores (all p≤0.01). Scores for satisfaction with desire and arousal on the Female Sexual Encounter Profile-Revised showed statistically significant improvement from baseline in Study 301 (p≤0.01) but did not reach statistical significance in Study 302.7 Changes in the number of satisfying sexual events (SSEs) showed some improvement but were not significantly different in either study.2
“We are very pleased that the Phase 3 study results showed robust and consistent efficacy across the co-primary and multiple secondary endpoints, indicating that Rekynda may be an effective option in increasing desire and decreasing distress associated with HSDD,” said Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “HSDD is an under-addressed medical condition that can significantly impact self-image, relationships and the general well-being of millions of women.”
The most frequent adverse events with Rekynda in both Phase 2 and Phase 3 clinical trials were nausea, flushing, and headache. These effects were generally mild-to-moderate in severity. Approximately 18 percent of patients in the Rekynda arm of the Phase 3 trials discontinued participation due to adverse effects. Rekynda has no known alcohol interactions.
DeRogatis L, Althof S, Clayton A, et al. Changes in Arousal and Desire in the Bremelanotide RECONNECT Study.
Revicki DA, Althof S, DeRogatis L, et al. Reliability and Validity of the Elements of Desire Questionnaire in the Bremelanotide RECONNECT Study.
Simon J, Portman D, Kingsberg S, et al. Bremelanotide (BMT) for Hypoactive Sexual Desire Disorder (HSDD) in the RECONNECT Study: Efficacy Analyses in Study Completer and Responders.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects approximately 15 million women in the U.S.3 and is characterized by low sexual desire that causes marked distress or relationship anxiety. Approximately 5.8 million pre-menopausal women have a primary diagnosis of HSDD.4,5,6 Patient awareness and understanding of the condition remain extremely low, and few women currently seek treatment.7 Recent market research indicates that 95 percent of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition.7 Furthermore, the majority of these women indicated a willingness to try a product like Rekynda, if recommended by their doctor.6
About Rekynda™ (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 single use, subcutaneous dose of 1.75 mg of Rekynda versus placebo, in each case, delivered via an auto-injector. 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 median 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 52 weeks. Nearly 80% of patients who completed the randomized portion of the study 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.
About Palatin Technologies
Forward Looking Statements
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: beliefs about the key symptoms of HSDD; the breadth of the female sexual dysfunction (FSD) and HSDD markets and Rekynda’s potential benefits and market potential; whether Rekynda met the threshold for achieving a clinically important difference for both desire and distress; beliefs that the results signal a meaningful impact of treatment on the sexual health of women; beliefs that the Phase 3 study results showed robust and consistent efficacy across co-primary and multiple secondary endpoints; whether Rekynda is an effective option in increasing desire and decreasing associated distress of HSDD and beliefs that HSDD can significantly impact self-image, relationships and the general well-being of millions of women are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
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 North America, (2) the possibility that significant safety or drug interaction problems could arise with respect to Rekynda, (3) the ability of AMAG to raise awareness and understanding of HSDD and the potential benefits of Rekynda, (4) uncertainties regarding the manufacture of Rekynda, (5) uncertainties relating to AMAG’s and Palatin’s patents and proprietary rights associated with Rekynda in North America, (6) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive financial results, (7) that AMAG or Palatin will fail to fully perform under the license agreement, (8) uncertainty regarding AMAG’s ability to compete in the FSD market in North America, and (9) other risks identified in AMAG’s Securities and Exchange Commission (SEC) filings, including AMAG’s Annual Report on Form 10-K for the year ended December 31, 2016, and Palatin’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 and subsequent filings by AMAG and Palatin with the SEC. AMAG and Palatin caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG and Palatin disclaim 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
- Simon J, Portman D, Kingsberg S, et al. Bremelanotide (BMT) for Hypoactive Sexual Desire Disorder (HSDD) in the RECONNECT Study: Efficacy Analyses in Study Completer and Responders.
International Society for the Studyof Women’s Sexual Health[abstract]. International Society for the Studyof Women’s Sexual HealthAnnual Meeting 2017; Atlanta, GA. Abstract no 017.
- DeRogatis L, Althof S, Clayton A, et al. Changes in Arousal and Desire in the Bremelanotide RECONNECT Study.
International Society for the Studyof Women’s Sexual Health[abstract]. International Society for the Studyof Women’s Sexual HealthAnnual Meeting 2017; Atlanta, GA. Abstract no 016. U.S. Census Bureau, 2014; Shifren et all, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008 U.S. Census Bureau, 2015 American Community Survey 1-Year Estimates
- 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, January 2017
Burke Institute: Patient and Economic Flow Study, April 2016 Burke Institute: Patient Segmentation Insights, August 2016
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