Schering Gets FDA OK For Premenstrual Disorder Product

Schering AG's (SHR) Berlex Inc. received Food and Drug Administration approval for Yaz as the only oral contraceptive to treat premenstrual dysphoric disorder, the company said Thursday.

Yaz, which got FDA approval to prevent pregnancy in March, can now be indicated to treat the disorder, which affects about 4.5 million women in the U.S., according to New Jersey-based Berlex.

Symptoms of the condition include mood swings, irritability, headaches, feeling anxious, bloating and food cravings. They regularly occur seven to 10 days before menstruation begins, and end within a few days after it started.

While the symptoms of PMDD and premenstrual syndrome are the same, women with PMDD experience five or more symptoms in a more severe way, the company said.

In addition, according to Kimberly Yonkers, associate professor in the Departments of Psychiatry and Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine, the syndrome is severe enough that it significantly interferes with relationships, social activities and work productivity.

"It is more than just a bad hair day," Yonkers said. "It really does rise to that level where somebody is affected in some important way."

Yonkers said about 20% of women have a clinically significant premenstrual condition, while 3% to 8% of women suffer from PMDD.

The professor said the condition can be treated by anti-depressant and anti-anxiety medications, which many women don't want to take and some clinicians are reluctant to use.

Yaz "actually gives both patients and clinicians another option," Yonkers said.

Although about 4.5 million women in the U.S. are affected by the disorder, nearly 90% remain undiagnosed and untreated, according to Berlex.

"Historically, some people have not taken the condition seriously, from doctors to patients," Yonkers said. "Some patients just think this is their lot in life and they have to put up with this...and they won't necessarily seek treatment for it."

Berlex said that in a parallel clinical trial in 450 women, Yaz significantly improved symptoms of premenstrual dysphoric disorder. The contraceptive was well tolerated by the majority of women in the conducted trials, it said.

The most common side effects of the drug were similar to other birth control pills and include upper respiratory infection, headache, breast pain, yeast infection, vaginal discharge, diarrhea and nausea.

Don Atkinson, president and general manager of female health care at Berlex, said the company expects sales of Yaz to go up "significantly" with the new indication. He declined to provide revenue from the birth-control pill since its March approval.

"We are really excited because Yaz takes oral contraceptives even further than they have ever been," Atkinson said. "This really changes what women can expect from an oral contraceptive."