FDA APPROVES ACNE INDICATION FOR BERLEX'S YAZ

Berlex, a U.S. affiliate of Bayer Schering Pharma, announced that the FDA has approved a new indication for Yaz (3 mg drospirenone/20 micrograms ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control.

With this decision, Yaz becomes the first and only oral contraceptive ever approved by the FDA for three distinct indications, according to Berlex. The drug received FDA approval as an oral contraceptive in March 2006 and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder in women who desire an oral contraceptive in October.

Unlike other progestins, drospirenone has a mild diuretic effect and antiandrogenic properties, which help the male sex hormones that can cause acne, according to the company.

Two six-month, multicenter, double-blind, placebo-controlled, randomized clinical trials in more than 1,000 patients revealed the statistically significant efficacy of Yaz in treating moderate acne. In the trials, treatment with Yaz resulted in significant reductions in total, inflammatory and non-inflammatory acne lesion counts.

The drug was well tolerated by the majority of women in these clinical studies. The most common side effects in the acne clinical trials include upper respiratory infection, irregular bleeding, headache, nausea, sinusitis and yeast infection.