WALTHAM, Mass., May 09, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today commended the recent action taken by the Centers for Medicare and Medicaid Services (CMS) to clarify statutory intent of section §1860D-2(e)(2)(A) of the Social Security Act, stating that drugs for the treatment of moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause, are not excluded from Medicare Part D coverage when used consistent with this labeling. This clarification should expand treatment options covered under Part D to include Intrarosa® (prasterone) vaginal inserts, the only locally administered, non-estrogen treatment alternative available to reduce moderate to severe dyspareunia due to menopause without an FDA boxed safety warning.
VVA, also referred to as genitourinary syndrome of menopause (GSM), is a chronic and progressive medical condition that is common in postmenopausal women due to decreases in androgens and estrogens at the time of menopause. Symptoms commonly include dyspareunia, vaginal dryness, and vaginal irritation. Unlike vasomotor symptoms of menopause (e.g., hot flashes and night sweats), VVA typically does not subside without treatment.
“Approximately half of all postmenopausal women will experience VVA at some point in their lives, making it a very common condition as women age,” said Julie Krop, M.D., chief medical officer and executive vice president, clinical and regulatory affairs, AMAG. “Given the detrimental effect that VVA and its symptoms such as dyspareunia may have on a woman’s health and well-being, we applaud CMS for taking this important step, and we look forward to working with Part D providers to help ensure that the millions of postmenopausal Medicare beneficiaries suffering from dyspareunia have access to the full range of potential treatment options.”
“The North American Menopause Society, along with other leading women’s health professional organizations, has long-recognized that dyspareunia in postmenopausal women is a symptom and consequence of vaginal atrophy,” said Sheryl Kingsberg, Ph.D., President, North American Menopause Society. “We are pleased that CMS has clarified its Part D coverage policy for treatment of dyspareunia as an underlying condition of menopause to reflect the medical community’s consensus on this issue.”
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 currently marketed products support the health of patients in the areas of maternal and women’s 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 Intrarosa® (prasterone)
Intrarosa is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa contains prasterone, a synthetic form of dehydroepiandrosterone (DHEA), which is an inactive endogenous sex steroid. Intrarosa is administered locally in the vagina, and is converted by enzymes in the body into androgens and estrogens. The mechanism of action is not fully established. In clinical studies, Intrarosa demonstrated efficacy through improvement in percentage of superficial cells and parabasal cells, pH and pain with intercourse.
Intrarosa is contraindicated in women with undiagnosed abnormal genital bleeding.
Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. Intrarosa has not been studied in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal pap smear. There were 11 cases of abnormal pap smears.
Please see full Prescribing Information available at www.intrarosa.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, statement regarding whether Intrarosa will be covered under Part D and our ability to help ensure that postmenopausal Medicare beneficiaries suffering from dyspareunia have access to the full range of potential treatment options; statements regarding the breadth of the VVA market and the effects of dyspareunia on a woman’s health and well-being; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine beliefs regarding AMAG’s development capabilities 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 other 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, 2017, its Quarterly Report on Form 10-Q for the quarter ending March 31, 2018 and subsequent filings with the SEC. 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® is a registered trademark of AMAG Pharmaceuticals, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc.
AMAG Pharmaceuticals, Inc.