U.S. FDA Approves Lower Dose Formulation of ANGELIQ® (Drospirenone and Estradiol) Tablets

WAYNE, N.J, Feb. 29, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a lower dose formulation of ANGELIQ^®  (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus.  The new formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2) and will be available in the U.S. by prescription shortly.

The previously approved prescription formulation of ANGELIQ contains 0.5 mg drsp/1 mg E2 and is indicated for the treatment of moderate to severe vasomotor symptoms and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause in women who have a uterus.

"We are pleased by the approval of this important new lower dose option for menopausal women," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "The availability of the new lower dose of ANGELIQ supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose."  

An estimated 6,000 women in the U.S. reach menopause every day,[1] and hormone therapy (HT) remains an important therapeutic option for menopausal women to discuss with their healthcare provider. 

Study Results

The new lower dose formulation of ANGELIQ is a once-daily tablet containing 0.25 mg drsp/0.5 mg E2 that significantly reduces the occurrence of moderate to severe vasomotor symptoms, such as hot flashes and night sweats, generally within four weeks of therapy initiation.  The efficacy of ANGELIQ 0.25 mg drsp/0.5 mg E2 for reducing the frequency and severity of moderate to severe vasomotor symptoms was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 735 postmenopausal women at least 40 years of age with a minimum of 7 to 8 moderate to severe hot flashes daily or 50 to 60 moderate to severe hot flashes weekly were randomized to one of the two doses of ANGELIQ, including 0.25 mg drsp/0.5 mg E2, estrogen monotherapy, or placebo. Efficacy for vasomotor symptoms was assessed during the 12 weeks of treatment.  Compared to placebo, subjects receiving ANGELIQ 0.25 mg drsp/0.5 mg E2, achieved statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms at Week 4 and Week 12. The mean difference in daily reduction of frequency of hot flashes between ANGELIQ 0.25 mg drsp/0.5 mg E2 and placebo was a decrease of approximately 2 episodes per day at Week 4 and a decrease of approximately 3 episodes per day at Week 12.  

Important Information About  ANGELIQ

What is the most important information I should know about ANGELIQ (combination of estrogen and progestin hormones)?

• Do not use estrogens with progestins, or estrogen-alone, to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
• Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
• Using estrogens with progestins, or estrogen-alone, may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• Using estrogen-alone may increase your chance of getting strokes, blood clots or cancer of the uterus (womb).
• You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ.
  

Who should not use ANGELIQ?

Do not use ANGELIQ if you have had your uterus removed (hysterectomy).  ANGELIQ contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use ANGELIQ.

Do not start taking ANGELIQ if you have unusual vaginal bleeding; currently have or have had certain cancers, such as cancer of the breast or uterus; had a stroke or heart attack in the past year; currently have or have had blood clots; have kidney disease, liver disease, or disease of your adrenal glands; have been diagnosed with a bleeding disorder; are allergic to ANGELIQ or any of its ingredients; or are pregnant or plan to become pregnant.

What are the most serious risks of taking ANGELIQ?

ANGELIQ may increase the risk of heart attack; stroke; blood clots; dementia; cancer of the breast, ovary, or lining of the uterus (womb); high blood pressure; high blood sugar; gallbladder disease; liver problems; or enlargement of benign tumors of the uterus (fibroids).

In addition, ANGELIQ contains drospirenone which may increase the potassium level in your blood. Do not take ANGELIQ if you have kidney, liver or adrenal gland disease because these conditions may also increase the potassium level in your blood. Tell your healthcare provider about all the medicines you take because some other medicines may increase potassium. In some situations, your healthcare provider may recommend testing your blood for potassium level.

Call your healthcare provider right away if you have:

• New breast lumps; changes in vision or speech; sudden new severe headaches; severe pain in your chest or legs with or without shortness of breath, weakness and fatigue

What are the most common side effects in ANGELIQ clinical trials?

The most common side effects are gastrointestinal (GI) and abdominal pain, female genital tract bleeding, breast pain/discomfort, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about ANGELIQ, please see full prescribing information, including boxed warning, at www.angeliq-us.com

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER^®, the Bayer Cross^® and ANGELIQ^® are all registered trademarks of Bayer.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.  

[1] The American Congress of Obstetricians and Gynecologists: 2011 Women's Health Stats and Facts, p. 33. http://www.acog.org/~/media/NewsRoom/MediaKit.ashx

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SOURCE Bayer HealthCare Pharmaceuticals Inc.