Wyeth announced that the US Food and Drug Administration (FDA) issued an approvable letter for Lybrel (90 µg levonorgestrel/20 µg ethinyl estradiol tablets), a low dose, continuous, non-cyclic combination oral contraceptive.
In response to the approvable letter, Wyeth will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data. The agency also indicated that it plans to convene a public meeting of contraceptive experts this year to discuss the clinical aspects of Lybrel. The anticipated topics include a review of the US Pearl Index [a calculation of the pregnancy rates among study participants], bleeding patterns, and the discontinuation rate among women in the study.
"Wyeth is confident that we can address the questions raised by the FDA, and we expect to move toward the launch of Lybrel," says Gary Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals.
Wyeth is seeking market approval for Lybrel, an investigational low dose combination oral contraceptive 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 daily dose of ethinyl estradiol and levonorgestrel, a well-studied combination. It is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval.
Oral contraceptives are not for every woman. Most related side effects are not serious. Serious side effects occur infrequently. Serious risks of all birth control pills that can be life threatening include blood clots, stroke, and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35. Women who use oral contraceptives should not smoke. Some women should not use oral contraceptives, especially women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding and those who are or may become pregnant. Oral contraceptives do not protect against HIV infection (AIDS) or sexually transmitted diseases.