Wyeth’s NDA for New Oral Contraceptive Accepted for Filing at FDA
Clinical Trials Evaluated Safety and Efficacy Data for Contraception as Well as Menses Inhibition
MADISON, N.J., July 27, 2005 -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for a new combination oral contraceptive containing levonorgestrel/ethinyl estradiol with a first-of-its-kind dosing regimen. The product is designed to be taken every day, without a placebo phase and eliminates the menstrual cycle, and may offer some women, over time, the potential to eliminate the associated bleeding. Wyeth is seeking market approval for the product 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 product will contain a low daily dose of ethinyl estradiol and levonorgestrel.
"This NDA is an important event in the evolution of oral contraceptives. No combination oral contraceptive is currently approved with this continuous, uninterrupted regimen," says Dr. Ginger Constantine, Vice President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals. "Wyeth developed this contraceptive so that women may have an additional option to manage their cycles. The studies to support this product are a reflection of our longtime commitment to innovation in women's health."
The NDA submission included data from two one-year Phase III clinical trials. These trials enrolled a total of 2,775 women and evaluated the safety and efficacy of the product for contraception. In addition, one of the secondary endpoints included was menses inhibition. In the clinical trials, the more commonly reported adverse events included headaches, vaginal bleeding and cramps.
Filing an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing does not indicate that approval has been or will be issued, nor does it represent an evaluation of the adequacy of the data submitted.
About Oral Contraceptives
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 the oral contraceptives, specially 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.
Posted: July 2005