FDA APPROVES NEW INDICATION FOR BERLEX'S ORAL CONTRACEPTIVE

Berlex, a U.S. affiliate of Schering AG, announced that the FDA has approved Yaz (3 mg drospirenone/20 micrograms 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. Yaz, which received FDA approval for the prevention of pregnancy in March, is the fastest growing oral contraceptive brand in the U.S., according to the company.

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. PMDD affects as many as 4.5 million women in the United States, and nearly 90 percent of these women remain undiagnosed and untreated.

In a multicenter, double-blind, randomized, parallel clinical trial of 450 women ages 18 to 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, a validated tool used to diagnose PMDD by tracking premenstrual symptoms and their severity on a daily basis. In a separate multicenter, placebo-controlled, randomized, crossover, confirmatory trial, patients experienced twice the improvement in symptoms scores versus placebo.