The RECONNECT Studies Demonstrated a Clinically Meaningful and Statistically Significant Improvement in the Co-Primary Endpoints of Desire and Associated Distress
WALTHAM, Mass., Oct. 11, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (AMAG) announced that the data from its two pivotal, double-blind placebo-controlled Phase 3 trials (RECONNECT) and its voluntary open-label one year extension studies were published in Obstetrics & Gynecology (the Green Journal). These publications are currently available online and will appear in the November print issue. In both randomized placebo-controlled clinical trials, Vyleesi™ (bremelanotide injection) met the pre-specified co-primary efficacy endpoints of improvement in desire and reduction in associated distress as measured by validated patient-reported outcome instruments. These endpoints are the hallmark symptoms of hypoactive sexual desire disorder (HSDD). The RECONNECT data from approximately 1,200 women was the basis for the June 2019 U.S. Food and Drug Administration approval of Vyleesi, the first and only as-needed treatment for premenopausal women with acquired, generalized HSDD.
"As a health care provider, I see first-hand how distress from low sexual desire significantly impacts my patients' lives," said Anita H. Clayton, M.D., Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, VA. "I'm excited that this publication will raise awareness of HSDD as well as potential treatment options."
While patients were still blinded to their treatment assignment, they were asked via a validated, questionnaire (GAQ-3), "Compared to the start of the study (prior to taking the study drug or placebo) to what degree do you think you have benefited from treatment?" Nearly 60 percent of patients taking Vyleesi reported feeling “better” to “very much better” compared to 36 percent of patients in the placebo group. Among those who completed the placebo-controlled, double blind portion of the study, approximately 80 percent of those women chose to continue to the voluntary open-label extension phase where all patients received study drug. Data from this 52-week open-label extension showed sustained efficacy for patients who had received study drug in the initial study and no new safety signals were observed. Additionally, patients who began taking study drug during the extension phase for the first time showed similar improvements in desire and reductions in associated distress to those seen during the randomized portion of the study in patients treated with study drug.
“The RECONNECT data support the consistent efficacy and long-term safety profile of Vyleesi,” said Julie Krop, M.D., Chief Medical Officer at AMAG. “AMAG is excited to be able to provide this important new therapy to patients and is committed to raising awareness of HSDD and making Vyleesi available to the approximately 6 million premenopausal U.S. women who suffer from this condition. I would like to thank the many women who made this possible by participating in our clinical trials.”
In the pivotal trials, the most common adverse events were nausea, flushing, injection site reactions, headache and vomiting. The majority of events were reported to be transient and mild-to-moderate in intensity. In the clinical trials, Vyleesi caused small, transient increases in blood pressure, and is contraindicated in women with uncontrolled high blood pressure or known cardiovascular disease.
About Vyleesi™ (bremelanotide injection)
Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector is self-administered into a woman’s abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Women should not inject more than one dose of Vyleesi within 24 hours of their last dose and should not inject more than eight doses of Vyleesi within a month. While the exact mechanism of action is unknown, Vyleesi is believed to bind to, and exert its effects via, melanocortin receptor agonism in the central nervous system.
The most common side effects of VYLEESI include nausea, flushing, injection site reactions and headache. Do not use VYLEESI if you are pregnant, or have uncontrolled hypertension, known heart disease or are taking oral naltrexone-containing products intended to treat opioid or alcohol addiction. Although less common, Vyleesi may also cause vomiting or darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast. Women who can become pregnant should use effective birth control during treatment with VYLEESI.
For additional product information, including full prescribing information, please visit www.vyleesi.com
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 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, beliefs about the size of the potential population for Vyleesi; statements about AMAG’s ability to make Vyleesi available to millions of women suffering with HSDD; statements about the publication’s ability to raise awareness of HSDD or Vyleesi and the belief that Vyleesi binds to melanocortin receptors in the central nervous system and that those receptors are associated with sexual dysfunction 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, the ability of AMAG to successfully execute on its commercialization plans and the level of market adoption for Vyleesi; the likelihood that healthcare providers, patients and/or healthcare payers will support the commercialization and use of Vyleesi; the risk that AMAG has over-estimated the size of the market for Vyleesi; as well as those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019 and subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”), 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.
AMAG Pharmaceuticals® and the logo are registered trademarks of AMAG Pharmaceuticals, Inc. Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc.
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