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 first scientific abstract reported on the return to menstruation after stopping the non-cyclic oral contraceptive (Lybrel). 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.
?When considering a non-cyclic oral contraceptive option, women want to know, once they stop use, when they will begin to menstruate again,? says Ginger Constantine, M.D., Vice President, Women?s Health Care and Bone Repair, Wyeth Pharmaceuticals. ?The findings presented at ACOG showed that most women in the study who took Lybrel returned to menses within three months.?
In the scientific abstract presenting the safety and efficacy profile of Lybrel compared with a traditional 21-day cyclic oral contraceptive in European women, the investigators reported that the oral contraceptive prevented pregnancies in all of the 323 women who took Lybrel. Three of the 318 participants who took the traditional 21-day cyclic oral contraceptive became pregnant. Previous studies in North America and the European U nion reported Pearl Indexes ranging from 1.60 to 1.33 respectively.
The New Drug Application (NDA) for Lybrel, accepted for filing on July 27, 2005, is under review by the U.S. Food and Drug Administration (FDA). If approved, Lybrel would be the first combination oral contraceptive taken 365 days a year without a placebo phase or pill-free interval.
The two trials of Lybrel, a continuous non-cyclic, low-dose, combination oral contraceptive for which an active pill is taken every day without a placebo interval, investigated return to menstruation after study participants stopped taking Lybrel, and the safety and efficacy of Lybrel compared with a traditional 21-day cyclic oral contraceptive.
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.