Barr Gets Approval for Extended Oral Contraceptive

NEW YORK (Reuters) - Barr Laboratories Inc. on Friday won U.S. regulatory clearance to market the first birth control pill designed to cut the number of a woman’s menstrual cycles to four a year from 13.

The company said the extended-cycle pill, called Seasonale, will be available by prescription at the end of October.

Women will take Seasonale tablets for up to 84 consecutive days, followed by a seven-day placebo interval. Most oral contraceptives currently sold in the United States are based on a regimen of 21 treatment days followed by seven days of placebo.

The placebo cycles allow for periods of bleeding, so most women on oral contraceptives have about 13 menstrual cycles each year that cleanse the linings of their wombs.

“It’s fantastic that women are going to have a choice about when and if they want to have periods,” said Dr. Anita Nelson, professor of obstetrics and gynecology at the University of California, Los Angles School of Medicine. “We’ve come to realize that the periods that women have when taking the pill are not menstruation, they’re artificial.”

Many doctors have for years prescribed oral contraceptives for the longer duration off-label to help women manipulate the frequency of their menstrual cycles, which for many can be accompanied by discomfort, pain and mood swings.

Barr Labs, based in Woodcliff Lake, New Jersey, decided to hold clinical trials of the contraceptives in order to get official FDA (news - web sites) approval for the extended cycle use.

The company effectively tested an older oral contraceptive called Nordette, originally made by Wyeth, for the longer duration.

Clinical trials of Seasonale found that it prevented pregnancy and was as safe as traditional birth control pills. The most common side effects were colds, headache and intramenstrual bleeding or spotting.

However, some health advocates oppose the idea of tinkering with the cycles, arguing that the bleeding is a necessary cleansing process and that to suppress it is unhealthy.

“Many women suffer significantly while they have their periods. If you can use the pills to take away periods entirely for three months or so at a time, that can make a huge contribution to women’s health, to their quality of life and to their productivity,” Nelson said.

The annual U.S. oral contraceptive market is about $2.8 billion and growing at 5 percent to 6 percent each year, according to a Barr spokeswoman.