Study Suggests that While All Postmenopausal Women Benefit from Treatment with Prasterone (INTRAROSA®), Women Experience Greatest Relief of Moderate to Severe Dyspareunia when started on INTRAROSA® within One to Two Years after Menopause
WALTHAM, Mass. and QUEBEC CITY, Quebec, Oct. 04, 2018 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Endoceutics today announced an oral presentation regarding the effect of time since menopause, age, and previous hormone therapy on treatment efficacy of intravaginal 6.5 mg prasterone (INTRAROSA®) at the Annual Meeting of The North American Menopause Society (NAMS) in San Diego, California. David F. Archer, M.D., NCMP, will present the study results on Thursday, October 4th from 5:15 PM to 5:30 PM.
Dr. Archer and colleagues analyzed combined data obtained from two prospective, randomized, double-blind, placebo-controlled clinical trials to evaluate the effect of daily intravaginal 6.5 mg INTRAROSA administered for 12 weeks to women who identified moderate to severe pain at sexual activity (dyspareunia) as their most bothersome symptom (MBS) of vulvar and vaginal atrophy, or VVA. The goal of the analysis was to assess the potential influence of time since menopause, age and previous hormone therapy on the response to treatment. Overall, there were 406 women treated with 6.5 mg INTRAROSA and 234 women who received placebo.
Women were divided into subgroups based upon time since menopause (1-2 years, 3-5 years and more than 6 years), age (older than or younger than 55 years old), and if they had ever taken hormone therapy. While age and prior hormone therapy did not influence the overall efficacy of INTRAROSA, the greatest reduction of dyspareunia had a tendency to be observed in women who were 1-2 years post menopause, compared to 3-5 years and more than 6 years post menopause, although the difference did not reach statistical significance.
“These findings reinforce the importance of education for women and healthcare providers regarding the high prevalence of VVA post menopause, and the need for appropriate early diagnosis and treatment,” said Brian Robinson, M.D., Senior Vice President, Medical Affairs, AMAG Pharmaceuticals. “It is well recognized that VVA symptoms, unlike hot flashes, are usually chronic and progressive. Given the tendency for vaginal atrophy to worsen over time without treatment, we would expect that initiating treatment closer to the onset of menopause would help mitigate progression to a more severe disease.”
Vulvar and vaginal atrophy, or VVA, affects approximately 50 percent of postmenopausal women in the United States, and painful sex is one of the most frequent symptoms.1 However, many women don’t attribute these symptoms to the decline in sex steroids that occur with menopause and may believe vaginal dryness and painful sex are simply an inevitable consequence of aging, thus delaying time to see their healthcare provider and receive appropriate treatment, thereby not only delaying therapy but potentially avoiding it altogether.
“Because many women prefer to avoid estrogen due to perceived safety concerns,2 I often see patients with advanced vaginal atrophy,” said David Archer, M.D., Director, CONRAD Clinical Research Center. “While generally reversible, I am pleased to be able to offer patients a non-estrogen treatment, without a boxed warning as they may be more willing to discuss treatment with their healthcare provider earlier. The data I will be presenting at NAMS reinforces the need for early identification and treatment, to potentially maximize reduction of pain during intercourse, and more importantly, avoid years of suffering and/or money spent on lubricants and moisturizers that don’t treat the underlying pathology of VVA.”
“INTRAROSA is the only vaginal non-estrogen treatment for moderate to severe painful sex due to menopause,” said Fernand Labrie, M.D., Founder, and President of Endoceutics. “It contains prasterone, a synthetic form of the endogenous prohormone DHEA which is converted intracellularly in the vagina into both androgens and estrogens. DHEA is very important since, after menopause, it becomes the only source of sex hormones. However, as a woman ages, DHEA decreases, thus being the main cause of the increase of menopausal symptoms.”
Safety and efficacy of INTRAROSA was demonstrated in the two aforementioned prospective, randomized, double-blind, placebo-controlled clinical trials, as well as a year-long safety study.3 INTRAROSA does not contain a boxed warning, nor does it have a restriction on the duration of use. Safety and efficacy of INTRAROSA was demonstrated in the aforementioned two pivotal studies, as well as a year-long safety study.
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.
About AMAG
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.
About Endoceutics
Endoceutics is a private pharmaceutical company operating in the field of women's health and hormone-sensitive cancer prevention and treatment. Following approval of Intrarosa® by the US FDA in November 2016 for the treatment of moderate to severe dyspareunia, a symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause as well as by the EU EMA in January 2018 for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms, Endoceutics has focused its efforts on developing non‑estrogen based therapies for sexual dysfunction and the other symptoms of menopause, including hot flushes, osteoporosis, muscle loss and type 2 diabetes. Hormonal therapies for breast, uterine and prostate cancer, male hypogonadism as well as endometriosis are also under development. Endoceutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to different product candidates addressing large market opportunities. For additional company information, please visit www.endoceutics.com.
Forward-Looking Statements
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, AMAG’s beliefs about the importance of education regarding the high prevalence of VVA post menopause to women and healthcare providers, AMAG’s expectations that initiating treatment closer to the onset of menopause would help mitigate progression to a more severe disease, beliefs about what women attribute menopause symptoms to and whether such symptoms are treatable and beliefs about women’s treatment preferences 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 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, 2017, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 and subsequent filings with 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® is a registered trademark of AMAG Pharmaceuticals, Inc. INTRAROSA® is a registered trademark of Endoceutics, Inc.
AMAG Pharmaceuticals, Inc. Contacts:
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1 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30 doi:10.4137/CMRH.S14498.
2 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30 doi:10.4137/CMRH.S14498.
3 Archer Menopause 2015; Labrie Menopause 2016 and Portman Menopause 2015.