WALTHAM, Mass. March 7, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that new and encore data related to bremelanotide and Hypoactive Sexual Desire Disorder (HSDD) will be presented at the upcoming International Society for the Study of Women’s Sexual Health (ISSWSH)/ International Society for Sexual Medicine (ISSM) Joint meeting taking place in Atlanta, Georgia on March 7-10.
“AMAG’s significant presence at this year’s ISSWSH/ISSM Joint Meeting underscores our deep commitment to raising awareness and understanding of HSDD, which is estimated to affect approximately one in ten premenopausal women in the United States,” said Julie Krop, M.D., chief medical officer and executive vice president of development at AMAG. “Women with this condition have low sexual desire or libido which often causes them to avoid intimacy, leading to self-esteem issues and stress in relationships. Despite the high prevalence of HSDD, there is a lack of awareness of this medical condition and an urgent need for safe and effective therapies.”
HSDD is characterized by low sexual desire and associated distress, and is thought to result from an imbalance in certain chemicals in the brain that affect sexual excitation or inhibition. In neuroimaging studies, women with HSDD show different brain responses to erotic stimuli compared to women with no HSDD. HSDD often negatively impacts women’s emotional health, intimate relationships, and overall quality of life.
“The ISSWSH/ISSM Joint Meeting attracts sexual health leaders from around the world so it is a great opportunity to present our data and engage in a dialogue on our findings,” continued Dr. Krop. “At this year’s meeting, we’ll share data summarizing the current clinical approach to the diagnosis and treatment of HSDD based on data we collected from medical chart reviews. We’ll provide additional data from our phase 3 clinical program for bremelanotide, an investigational drug which is under review with the U.S. Food and Drug Administration (FDA) and has a June 23, 2019 PDUFA date. This data includes a poster on patient experiences with the drug during the phase 3 trials and an original oral presentation on the consistent efficacy of bremelanotide independent of baseline testosterone levels.”
The safety and efficacy of bremelanotide has not been established by FDA.
Research Podium Session
- Bremelanotide for Hypoactive Sexual Desire Disorders in the RECONNECT Studies: Analysis of Baseline Free Testosterone Level Quartile Subgroups (#029); Clayton et al.; Sunday, March 10, 8:40-8:50 a.m. EST
Research Poster Sessions
- Women’s Experiences With Bremelanotide Administered, On Demand, for the Treatment of Hypoactive Sexual Desire Disorder (#080); Koochaki et al.; Saturday, March 9; 6:00-7:30 p.m. EST
- Describing the Clinical Approach to Diagnosis and Treatment of Patients With Hypoactive Sexual Desire Disorder (#086); Parish et al.; Saturday, March 9; 6:00-7:30 p.m. EST
- There’s Something Missing: Understanding Her Journey with HSDD; Speakers, Brooke M. Faught, DNP, WHNP-BC, NCMP, IF, Director of the Women’s Institute for Sexual Health (WISH), Division of Urology
Associates and Risa Kagan, MD, FACOG, CCD, NCMP Clinical Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, UCSF, Sutter East Bay Physicians Medical Group;
Saturday, March 9, 2019, 12:30 p.m. – 1:30 p.m. EST
Bremelanotide, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. Bremelanotide is designed to be used in anticipation of a sexual encounter, and is thought to possess a novel mechanism of action that impacts the excitatory neural pathways in the brain to restore sexual desire.
Bremelanotide has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s New Drug Application to the FDA was supported by clinical data from two large double-blind placebo-controlled Phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes. Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 12 months. Nearly 80 percent of patients elected to remain in the open-label portion of the study, and all of these patients received bremelanotide.
The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity. Bremelanotide has no known alcohol interactions.
Bremelanotide is protected by a number of U.S. and foreign patents and applications that are owned by Palatin Technologies, Inc. Certain of the patents include claims directed to the bremelanotide drug composition and methods of use thereof with terms expiring in 2020, and other patents include claims directed to methods of treating female sexual dysfunction by subcutaneous administration of compositions that include bremelanotide with terms expiring in 2033.
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, among others, statements regarding the prevalence of HSDD in the U.S. and the lack of awareness about the condition and statements about the potential cause of HSDD and how it impacts women’s lives, 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, among others, those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10‐K for the year ended December 31, 2018 and subsequent filings with the SEC, including Current Reports on Form 8-K, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward‐looking statements, which speak only as of the date they are made.
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.
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