U.S. FDA Approves First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)

WAYNE, N.J., March 14, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Natazia® (estradiol valerate and estradiol valerate/dienogest) tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive (OC) for contraception.  With this approval, Natazia is the first and only oral contraceptive indicated for the treatment of HMB.

Natazia was approved in May 2010 for the prevention of pregnancy.  The contraceptive efficacy of Natazia has not been evaluated in women with a body mass index (BMI) greater than 30 kg/m2.

"Heavy menstrual bleeding is a common disorder reported by around three million women of reproductive age each year in the United States[1]," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."

Recognized signs of HMB may include menstrual flow that soaks through one or more sanitary pads or tampons every hour, the need to use double sanitary protection to control heavy flow, or the need to wake up to change sanitary protection during the night.[2]

About the HMB Clinical Program for Natazia

The approval of Natazia for this HMB indication was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials – one in North America and one in Europe and Australia.  The studies included a total of 421 women, who were 18 years of age or older, with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. 

Subjects were treated for seven 28-day cycles with either Natazia or placebo. The proportion of the intent-to-treat subjects with complete symptom relief (based on 8 strictly defined criteria for success during the 90-day efficacy assessment phase) was 29.2 percent in the Natazia group compared to 2.9 percent in the placebo group in the first study and 29.5 percent in the Natazia group compared to 1.2 percent in the placebo group in the second study.  Patients with HMB (defined as menstrual blood loss of 80 mL or more in at least 2 bleeding episodes during a 90-day run in phase) who were treated with Natazia achieved a statistically significant reduction in menstrual blood loss compared with patients in the placebo group (p<0.0001 for both studies).

Most common adverse reactions (greater than or equal to two percent) in Natazia clinical trials included headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes, and weight gain.

Important Safety Information About Natazia®

Who should not take Natazia?

Do not use Natazia if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking Natazia?

Natazia increases the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use.  This risk is greatest when first starting the Pill and when restarting the same or a different Pill after a 4 week or greater break.

Call your healthcare provider right away if you have:

• Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes

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

The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea/vomiting, acne, mood changes, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

Natazia does not protect against HIV infection (AIDS) or other STDs.

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 Natazia, please see full prescribing information, including boxed warning, at www.natazia.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 Natazia® are all registered trademarks of Bayer. 

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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] Lumsden MA, Wedisinghe L. Tranexamic acid therapy for heavy menstrual bleeding. Expert Opin.  
  Pharmacother. 2011 12(13): p. 2089.

[2] MayoClinic, Menorrhagia (heavy menstrual bleeding). Available at: http://www.mayoclinic.com/health/menorrhagia/DS00394/DSECTION=symptoms [accessed on March 14, 2012]

SOURCE Bayer HealthCare Pharmaceuticals Inc.