First scientific data for Lybrel presented at ASRM meeting

Madison, N.J., Wyeth Pharmaceuticals, a division of Wyeth, announced that four scientific abstracts regarding Lybrel� (0.09 mg levonorgestrel/0.02 mg ethinyl estradiol tablets) were presented for the first time today at the 61st Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Montr�al, Canada.

The studies investigated the effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol on ovarian activity, safety and efficacy, endometrial histology, and cycle-related symptoms. The New Drug Application (NDA) for the study drug, Lybrel, a combination low-dose oral contraceptive designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval, was accepted for filing on July 27, 2005 and is currently under review by the U.S. Food and Drug Administration (FDA).

The research presented at the ASRM Annual Meeting includes investigational data on multiple effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol. The abstracts accepted for presentation are:

Investigation of Ovarian Activity

A six-month Phase 2 study entitled �Effect on Ovarian Activity of a Continuous-Use Regimen of Oral Levonorgestrel/Ethinyl Estradiol� reported that participants (n=37) taking 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol experienced inhibition of ovulation. The study also reported that participants who stopped the study drug treatment demonstrated a return to ovulation. This was the first ever published investigational study of a combination oral contraceptive designed to be taken every day of the year without a placebo phase to specifically evaluate ovarian suppression and return to ovulation.

Investigation of Safety and Efficacy

An abstract entitled �Efficacy and Safety of a Continuous-Use Regimen of Levonorgestrel/Ethinyl Estradiol: North American Phase 3 Study Results� examined the contraceptive effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol and the adverse events experienced by the study participants (n=2,134) during the 12-month trial. Contraceptive efficacy was determined by the Pearl Index, a calculation of the pregnancy rate among study participants.