Women looking for a simple way to avoid their menstrual period could soon have access the first birth control pill designed to let women suppress monthly menstrual bleeding indefinitely.
The U.S. Food and Drug Administration is expect to announce approval for Lybrel, a drug from Wyeth (NYSE:WYE) which would be the first pill to be taken continuously.
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced that two new scientific abstracts relating to the investigational, combination oral contraceptive Lybrel? (90 ?g levonorgestrel/20 ?g ethinyl estradiol tablets) were presented this week at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting in Washington, D.C.
The study showed that 99 percent of 187 participants experienced either a return to menses or became pregnant within 90 days after stopping the study drug. Investigators reported that four women became pregnant before returning to menses and two women reported a return to menses more than 90 days after the completion of the study.
Gynecologists say they’ve been seeing a slow but steady increase in women asking how to limit and even stop monthly bleeding. Surveys have found up to half of women would prefer not to have any periods, most would prefer them less often and a majority of doctors have prescribed contraception to prevent periods.
In addition to the FDA, the New Drug Application (NDA) for 90 ?g levonorgestrel/20 ?g ethinyl estradiol tablets is under review in Canada and the European U nion. Wyeth is seeking market approval for Lybrel for the prevention of pregnancy in women who elect to use oral contraception and who have no known contraindications for this method of contraception.
If approved, this investigational product will contain a low dose of ethinyl estradiol and levonorgestrel, a well-studied combination. It is expected to be the only combination oral contraceptive approved that is designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval. If approved, this product will also allow a woman to reduce the hormonal fluctuations associated with the entire menstrual cycle.