-Data Evaluate the Time to Return to Menses After Stopping Lybrel and
Safety and Efficacy-
MADISON, N.J., May 8 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), 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.
SOURCE Wyeth
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CONTACT:
Media, Candace Steele, +1-484-865-5428, or
Christopher Garland, +1-484-865-6323, both for Wyeth
Pharmaceuticals or Investor, Justin Victoria of Wyeth,
+1-973-660-5340
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