Healthcare Industry News: estradiol
News Release - May 22, 2007
FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women the Opportunity to Be Period-Free Over TimeCOLLEGEVILLE, Pa., May 22 (HSMN NewsFeed) -- 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.
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 www.Wyeth.com.
Source: Wyeth Pharmaceuticals
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