MADISON, N.J., May 8 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that two new scientific abstracts relating to the investigational, combination oral contraceptive Lybrel(TM) (90 micrograms levonorgestrel/20 micrograms 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 Union 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. Additional information about the abstracts presented at ACOG:
Abstract: Return to Menses After Continuous Use of a Low-Dose Oral Contraceptive
The scientific abstract of the U.S. clinical trial examining the return to menses after stopping use of the non-cyclic oral contraceptive in 187 women who took 90 micrograms levonorgestrel/20 micrograms ethinyl estradiol tablets for a median of 364 days reported that menstruation returned or pregnancy occurred in 99 percent of participants within 90 days after stopping the study drug. This study reported that 38.5 percent of women experienced a return to menses in 30 days, and 92.5 percent of participants had experienced menses within 60 days.
“Participants in this trial who took the non-cyclic study drug [Lybrel] returned to menses without significant delay once they stopped the regimen,” says Anne R. Davis, M.D., Assistant Professor of Clinical Obstetrics and Gynecology at Columbia University and primary investigator for the study.
Abstract: Comparative Trial of Continuous-Use and 21-Day Cyclic Levonorgestrel/Ethinyl Estradiol Oral Contraceptives
This scientific abstract reported on the comparative Phase 3 study conducted at 44 sites in Europe and examined the oral contraceptive Lybrel [90 micrograms levonorgestrel/20 micrograms ethinyl estradiol tablets] and a traditional 21-day [100 micrograms levonorgestrel/20 micrograms ethinyl estradiol tablets] oral contraceptive.
Among the 641 trial participants, the safety profile of the investigational, non-cyclic oral contraceptive was reported as similar to that of a traditional, cyclic oral contraceptive. Study authors noted that, over time, a majority of women taking the Lybrel during a one-year (13 pill packs) study reported amenorrhea (27.1 percent, 39.6 percent, and 52.9 percent of subjects reported amenorrhea at pill packs three, seven and 13, respectively). Study investigators also evaluated no-bleeding, i.e., breakthrough bleeding without the need for sanitary protection, in the non-cyclic regimen users and reported an increase in participants with no bleeding with each subsequent pill pack (50 percent, 69 percent, and 79 percent of subjects did not require sanitary protection at pill packs three, seven and 13, respectively).
After pill pack four, women taking the investigational, non-cyclic pill experienced a fewer number of median breakthrough bleeding days than women taking the traditional, cyclic pill. After pill pack six, bleeding-related adverse events were not significantly different between those taking the investigational and traditional oral contraceptive regimens. Reported nausea and breast pain were lower with the non-cyclic pill during pill packs seven to 13.
“These new data reported that the non-cyclic oral contraceptive pill had a similar safety profile as an established 21-day regimen,” says Alexander Teichmann, M.D., Ph.D., Professor at Frauenklinik Klinikum Aschaffenburg in Germany and primary investigator for the study.
About Lybrel
In addition to the FDA, the New Drug Application (NDA) for 90 micrograms levonorgestrel/20 micrograms ethinyl estradiol tablets is under review in Canada and the European Union. 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.
About Oral Contraceptives
Oral contraceptives are not for every woman. Most related side effects are not serious, and 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.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (Lybrel and our other pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors.” We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Wyeth
CONTACT: Media, Candace Steele, +1-484-865-5428, or Christopher Garland,+1-484-865-6323, both for Wyeth Pharmaceuticals or Investor, JustinVictoria of Wyeth, +1-973-660-5340
Web site: http://www.wyeth.com/
