The First FDA-Approved As-Needed Treatment for Premenopausal Women
Experiencing Low Sexual Desire and Associated Distress Now Available to Patients
WALTHAM, Mass. August 27, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now commercially available through specialty pharmacies, Avella and BioPlus. Once prescribed, Vyleesi is delivered directly to a woman’s home. Vyleesi is the first treatment for this patient population that can be self-administered in anticipation of sexual activity.
“In my practice I see many women who suffer from HSDD, a medical condition which impacts approximately 1 in 10 U.S. women,” said Brooke Faught, DNP, WHNP-BC, NCMP, IF, Director of the Women’s Institute for Sexual Health. “HSDD can significantly impact self-esteem, body image, and intimate relationships. I’m excited that I can now offer my patients suffering from this important condition a treatment option that can be delivered on an as needed basis.”
AMAG is committed to working with payers and healthcare professionals to help ensure that the millions of eligible premenopausal women suffering with HSDD have access to Vyleesi. To help women access treatment, AMAG is currently offering a copay assistance program so that eligible patients will be able to obtain their first four-pack of Vyleesi auto-injectors for $0. Under the current program, women who choose to refill their prescription can receive a four-pack of Vyleesi for no more than $99. Based on usage in clinical trials, a 4-pack is likely to last patients, on average, 6-8 weeks.
“The team has been working diligently and is excited to make Vyleesi available to the nearly six million premenopausal women suffering with HSDD,” said Tony Casciano, chief commercial officer at AMAG. “We’ve been educating healthcare providers about Vyleesi with a select group of our sales representatives across the U.S. over the last few weeks through our early experience program. We are happy to report that last week we shipped our very first 4 packs of Vyleesi to patients through our specialty pharmacy partners. We look forward to launching nationally with our full sales force in mid-September.”
Patients who would like to learn more about HSDD and Vyleesi as a potential treatment option should speak to a healthcare professional. One way patients can do that is to schedule a telemedicine appointment with Plushcare, an independent telemedicine service. Patients may access Plushcare from the product website, www.vyleesi.com. Healthcare professionals are encouraged to visit https://vyleesipro.com/ to learn more.
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 pen 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. Vyleesi is thought to possess a novel mechanism of action. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system.
The most common side effects of VYLEESI include nausea, flushing, injection site reactions, headache and vomiting. 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. 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 and that its copay program will help women access Vyleesi; and plans to leverage AMAG’s sales force 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. and Makena® is a registered trademark of AMAG Pharma USA, Inc.
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