New cream for vaginal dryness approved

Dec 1 2008

Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream.

SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause. It is administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week.

SCE-A Vaginal Cream will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in the second quarter of 2009 utilizing direct sales force activities as well as other indirect marketing initiatives.

"SCE-A Vaginal Cream offers an additional treatment option to women and healthcare professionals," said Fred Wilkinson, Duramed's Chief Executive Officer. "With its unique indication and dosing regimen, it is designed to complement our existing line of plant-derived estrogen therapies for the treatment of post-menopausal symptoms."

According to the North American Menopause Society (NAMS), an estimated 10 to 40 percent of post-menopausal women suffer from symptoms related to vaginal atrophy(1). Two of the most common symptoms of vaginal atrophy are vaginal dryness and pain with intercourse(2). The symptoms of vaginal atrophy are most commonly associated with diminished estrogen levels that accompany menopause(1). If left untreated, vaginal atrophy may result in years of discomfort.(1)

SCE-A Vaginal Cream is indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy associated with menopause. The most common side effects in the clinical trials (>3%) were vulvovaginal infections, upper respiratory tract infection, headaches and hot flashes.

SCE-A Vaginal Cream should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of certain cancers; stroke or heart attack in the past year; currently having or having had blood clots or thromboembolic disease including stroke or myocardial infarction; or liver problems; allergy to SCE-A Vaginal Cream or any of its ingredients; or known or suspected pregnancy.

Menopause is the time in a woman's life when the menstrual period ceases and the ovaries permanently stop releasing eggs. Menopause is considered complete when a woman has been without her period for a full year. While some women experience no menopausal symptoms, others suffer severe symptoms that require treatment. Vasomotor symptoms (night sweats, hot flashes) and vaginal symptoms (such as vaginal dryness and pain with intercourse) are common menopausal symptoms. Although the majority of women experience "natural" or spontaneous menopause, some women may experience menopause due to a medical intervention such as surgery, chemotherapy or radiation.

(2) Bachman Ga, Ebert GA, Burd ID. Vulvovaginal Complaints. In: Lobo RA, ed. Treatment of the Postmenopausal Woman: Basic and Clinical Aspects. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999:195-201

Patients should consult their healthcare providers about whether they need treatment with SCE-A Vaginal Cream to control their symptoms. If a patient has a uterus, she should talk to her healthcare provider about whether the addition of progestin should be considered, as there is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

Cardiovascular Disorders and Probable Dementia

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

The estrogen-alone sub-study of Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) relative to placebo.

The estrogen-plus-progestin sub-study of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a sub-study of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

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