US Food and Drug Administration has accepted for filing Wyeth Pharmaceuticals’ 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,” Dr. Ginger Constantine, Vice President, Women’s Health Care and Bone Repair, Wyeth Pharmaceuticals said adding, “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 long-time 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.