Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the
U.S. Food and Drug Administration (FDA) has approved the oral contraceptive
Lybrel(TM) (90 mcg levonorgestrel/20 mcg ethinyl estradiol) tablets for the
prevention of pregnancy in women who elect to use oral contraceptives and
who have no known contraindications for this method of contraception.
Lybrel is the first and only low dose combination contraceptive pill taken
365 days a year, without a placebo phase or pill-free interval. Available
by prescription, Lybrel is expected to be in U.S. pharmacies in July 2007.
Lybrel is intended for women who are seeking contraception and who are
interested in putting their menstrual cycle on hold. Lybrel provides a
steady low dose of hormones so that over time women may become cycle-free.
Women considering Lybrel should know that most subjects in the clinical
studies experienced some breakthrough bleeding and spotting, especially
during the first three to six months. In studies and analyses, Lybrel did
not delay a return to fertility nor did it affect return to menses.
As part of a postmarketing commitment, Wyeth will conduct a study of
thromboembolic events among women prescribed Lybrel compared to women
prescribed cyclic oral contraceptives containing 20 mcg ethinyl estradiol.
"For those women seeking contraceptive options and who are interested
in putting their period on hold," says Ginger Constantine, M.D., Vice
President, Women's Health Care, Wyeth Pharmaceuticals, "Lybrel may be an
appropriate choice."
Studies Help Establish Safety and Efficacy Profile
Worldwide clinical trials involving 2,457 women demonstrated the
efficacy of Lybrel. Lybrel had comparable contraceptive efficacy similar to
other FDA- approved oral contraceptives. Breakthrough bleeding and spotting
were also evaluated and were shown to lessen over time. The bleeding
pattern was categorized in clinical trials as breakthrough bleeding that
requires sanitary protection or spotting that did not require sanitary
protection. There were 860 women who met criteria for evaluation and
completed pill pack 13. During pill pack 13 (28-day interval):
-- 59 percent of women achieved amenorrhea (defined as absence of all
bleeding and spotting)
-- 20 percent of women experienced spotting only, not requiring any
sanitary protection
-- 21 percent of women required sanitary protection due to breakthrough
bleeding
The Lybrel safety and efficacy study was published in the December 2006
issue of the journal Contraception.
In a clinical trial, the incidence of serious adverse events was low
and was similar to another FDA-approved oral contraceptive. Unscheduled
bleeding or spotting is likely to occur while you are taking Lybrel. The
convenience of having no regular menstrual periods should be weighed
against the inconvenience of unscheduled or unplanned breakthrough bleeding
or spotting.
Because regular monthly bleeding does not occur on Lybrel, an
unexpected pregnancy may be difficult to recognize. If you suspect you may
be pregnant or if you have symptoms of pregnancy such as nausea/vomiting or
unusual breast tenderness, a pregnancy test should be performed and you
should contact your health care professional.
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 those over 35. Women using oral contraceptives
should not smoke. Some women should not use oral contraceptives, especially
those 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.
Gallup Survey
Wyeth commissioned the Gallup Organization to conduct a national study
on the knowledge and attitudes of women and health care practitioners
toward oral contraceptives used in menstrual suppression. The results are
based on telephone interviews conducted by Gallup's executive and medical
interviewer team during April and May, 2006.
In the survey, approximately 97 percent of OB-GYNs thought it is safe
to use oral contraceptives continuously, without a placebo phase, in the
appropriate patient population. The survey polled 205 OB-GYNs and 200 nurse
practitioners.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
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 the inherent uncertainty of the
timing and success of, and expense associated with, research, development,
regulatory approval and commercialization of our products, including with
respect to our pipeline products; government cost-containment initiatives;
restrictions on third-party payments for our products; substantial
competition in our industry, including from branded and generic products;
data generated on our products; the importance of strong performance from
our principal products and our anticipated new product introductions; the
highly regulated nature of our business; product liability, intellectual
property and other litigation risks and environmental liabilities;
uncertainty regarding our intellectual property rights and those of others;
difficulties associated with, and regulatory compliance with respect to,
manufacturing of our products; risks associated with our strategic
relationships; economic conditions including interest and currency exchange
rate fluctuations; changes in generally accepted accounting principles;
trade buying patterns; the impact of legislation and regulatory compliance;
risks and uncertainties associated with global operations and sales; 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." The forward-looking statements in this
press release are qualified by these risk factors. We assume no obligation
to publicly update any forward-looking statements, whether as a result of
new information, future developments or otherwise.
For more information, visit Wyeth.
Wyeth Pharmaceuticals
Wyeth
View drug information on Estradiol Transdermal System.