There are an estimated 64 million post-menopausal women in the U.S., and as many as 32 million women suffer from VVA symptoms.1 Studies suggest that between 44 percent and 78 percent of women with VVA suffer from dyspareunia.2,3 According to patient survey data, more than half of women who report symptoms of dyspareunia are not currently being treated with a prescription therapy or seeking treatment.4
"Intrarosa will address an important unmet need as a novel treatment for moderate-to-severe dyspareunia due to menopause and it represents a significant commercial opportunity,” said
Intrarosa contains prasterone, an inactive steroid hormone that is converted locally inside the vaginal cells into androgens and estrogens. This intracellular production does not result in clinically meaningful increases in blood concentrations. The Intrarosa label does not carry the boxed warnings currently included in the labels of conventional estrogen-containing medications which highlight the increased risk of certain types of cancers, such as endometrial cancer, as well as cardiovascular disorders and probable dementia. The most common adverse reactions are vaginal discharge and abnormal Pap smears, predominantly composed of atypical cells of undetermined significance (ASCUS). Intrarosa has not been studied in women with a history of breast cancer.
Intrarosa was approved in
About IntrarosaTM (Prasterone)
Intrarosa is the only locally administered, daily non-estrogen steroid hormone approved by the
In two primary 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in symptoms of dyspareunia, as well as significant improvements in the percentage of vaginal superficial cells and parabasal cells, as well as vaginal pH. In clinical trials, the most common adverse reactions were vaginal discharge and abnormal Pap smears, predominantly composed of atypical cells of undetermined significance (ASCUS). Intrarosa has not been studied in women with a history of breast cancer.
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 women’s and maternal 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.
This press release contains forward-looking information about
Such risks and uncertainties include, among others, (1) the possibility that AMAG will not realize the expected benefits of the transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize Intrarosa; (2) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (3) the ability of AMAG to drive awareness of dyspareunia and the potential benefits of Intrarosa; (4) uncertainties regarding the manufacture of Intrarosa; (5) uncertainties relating to patents and proprietary rights associated with Intrarosa in
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.
1 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30.
3 F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The
4 Multiple publications based on patient surveys.
Linda LennoxVice President, Investor Relations 908-627-3424 Media: Katie PayneVice President, External Affairs 202-669-6786