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Oct 5 2006, 3:30 AM EST

FDA Approves New Indication for YAZ(R) to Treat Emotional and Physical Symptoms of Premenstrual Dysphoric Disorder (PMDD)

PRNEWSWIRE

WAYNE, N.J., Oct. 5 /PRNewswire/ -- 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 YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) as the first and only oral contraceptive shown clinically effective for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. YAZ, which received FDA approval for the prevention of pregnancy in March, 2006, is the fastest growing oral contraceptive brand in the U.S.*

PMDD is a condition in which women's emotional and physical premenstrual symptoms are disruptive enough to significantly impact relationships, social activities and work productivity. Symptoms of PMDD include mood swings, irritability, headaches, feeling anxious, bloating and food cravings. The symptoms regularly occur seven to 10 days before menstruation begins, and resolve within a few days of the onset of menses. While the symptoms of PMDD and premenstrual syndrome (PMS) are the same, women with PMDD experience five or more symptoms which are more severe. PMDD affects as many as 4.5 million women in the United States, and nearly 90 percent of these women remain undiagnosed and untreated. PMDD is also linked to higher healthcare costs related to more frequent visits to healthcare providers, decreased work productivity and absenteeism.

"For years, women overwhelmingly told us that they want more from their birth control pill than just reliable contraception," says Reinhard Franzen, President and CEO of Berlex. "Very high on their list of desired added benefits was the relief from the impact of menstrual symptoms. We knew that our innovative progestin, drospirenone, held promise due to its unique properties. We are very happy that we can now offer YAZ as an effective contraceptive, as well as a treatment for mood swings, bloating, and other symptoms of PMDD."

YAZ is the first birth control pill shown to treat the emotional and physical symptoms of PMDD. YAZ combines the innovative progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Unlike other progestins, drospirenone has a mild diuretic effect (antimineralocorticoid property). Further, drospirenone has been shown to block the effects of male hormones in a woman's body (antiandrogenic property**). In addition, the 30-hour half life of drospirenone combined with the 24-day active hormone pill regimen result in less hormonal fluctuation during the menstrual cycle.

"Unlike other oral contraceptives, YAZ delivers the progestin, drospirenone, in combination with estrogen in a unique 24-day dosing regimen, both of which may account for its positive effect on PMDD," said Andrea Rapkin, M.D., Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine, UCLA. "For my PMDD patients who need a treatment to reduce their symptoms, as well as a safe and effective contraceptive to prevent pregnancy, YAZ is an important option that can meet both of their healthcare needs in a single pill."

PMDD Clinical Study Results

In a multicenter, double-blind, randomized, parallel clinical trial of 450 women aged 18-40 with symptoms of PMDD, YAZ was significantly superior to placebo in improving interpersonal relationships, work productivity and enjoyment of hobbies/social activities. Forty-eight percent of YAZ patients experienced a reduction in symptom severity by at least half, as measured by the Daily Record of Severity of Problems(1), a validated tool used to diagnose PMDD by tracking premenstrual symptoms and their severity on a daily basis.

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