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FDA Approves Angeliq To Treat Menopausal Symptoms

MONTVILLE, N.J., Sept. 29 /PRNewswire-FirstCall/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) has approved ANGELIQ(R) (drospirenone and estradiol) to treat moderate to severe vasomotor symptoms associated with menopause. ANGELIQ will be the only hormone therapy to contain the unique progestin, drospirenone.

"ANGELIQ provides menopausal women and healthcare professionals with a new treatment option containing the progestin, drospirenone, which is also found in YASMIN(R), the number-one brand of oral contraceptive in the U.S. and worldwide," said Reinhard Franzen, President and CEO of Berlex Laboratories. "The largest growing group of women over age 50 are those between 50 and 54, which is typically when women experience the symptoms of menopause and seek ways to treat them."

The estrogen component in ANGELIQ is estradiol, the same estrogen produced by the ovaries prior to menopause. The progestin drospirenone is a spironolactone analog with anti-aldosterone activity, a property that can cause the excretion of excess sodium and water while retaining potassium levels. Women with liver, kidney, or adrenal disease should not take ANGELIQ.

Patients taking drugs that could increase potassium should consult their health care professional before taking ANGELIQ.

ANGELIQ will be available in the U.S. by prescription in mid-2006, in a preparation containing 0.5 mg drospirenone and 1 mg estradiol.

"It is more important than ever for women to have a variety of hormone therapy options because one particular therapy will not be optimal for all women," said David Archer, M.D., Director of Clinical Research at the Contraceptive Research and Development Program of Eastern Virginia Medical School in Norfolk, and ANGELIQ clinical investigator. "Estrogen is still the most effective way to manage the symptoms of menopause, but by combining estrogen with new and different progestins, each with unique biologic profiles, we better enable clinicians to tailor treatment for individual patients." Dr. Archer will be presenting data on ANGELIQ at the 16th annual meeting of the North American Menopause Society taking place in San Diego, California on Friday, September 30, 2005.

Study Results
ANGELIQ quickly treats the occurrence of moderate to severe vasomotor symptoms, such as hot flashes, night sweats and vulvar and vaginal atrophy, generally within four weeks of therapy initiation.

ANGELIQ was studied in several large-scale clinical trials involving more than 1,759 postmenopausal women that established the safety and efficacy in providing endometrial protection, and an acceptable bleeding profile. Use of ANGELIQ among women who participated in clinical studies was associated with high rates of acceptability and compliance, and a low discontinuation rate due to side effects. The most common side effects, including vaginal bleeding, breast pain and headaches, were mild and transitory and similar to those of other hormonal therapies.

Important Information About ANGELIQ and YASMIN
Due to the fact that drospirenone may increase potassium levels in some patients, women with liver disease, kidney disease, or adrenal disease should not take ANGELIQ or YASMIN.

Patients taking drugs that could increase potassium should consult their health care professional before taking ANGELIQ or YASMIN; consideration should be given to test serum potassium levels in the first treatment cycle in these ANGELIQ users. Women taking YASMIN who are receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle.(1)

Important Information About all Hormone Therapy
The Women's Health Initiative (WHI) study 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 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. 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.

The Women's Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens, plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger post-menopausal women.

Estrogens and estrogen/progestin therapy should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; blood clots; stroke or myocardial infarction; known or suspected pregnancy, and liver dysfunction or disease. ANGELIQ should not be used in patients with known hypersensitivity to its ingredients.

For more information and full prescribing information, please visit http://pharma.bayer.com/en/.

Source: Berlex, Inc.

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