Collegeville, Pa., May 22, 2007 – 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™ (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 post marketing 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):
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.
WASHINGTON - The first birth-control pill meant to put a stop to women's monthly periods indefinitely won federal approval.
Called Lybrel, it's the first such pill to receive
Food and Drug Administration approval for continuous use. When taken daily, the pill can halt women's menstrual periods indefinitely and prevent pregnancies.
Lybrel is the latest approved oral contraceptive to depart from the 21-days-on, seven-days-off regimen that had been standard since birth-control pill sales began in the 1960s. The pill, manufactured by Wyeth, is the first designed to put off periods altogether when taken without break.
The pill isn't for everyone, an FDA official said. About half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA's drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation.
"If you think you don't want to go down this road, this is not for you," Shames told reporters.
Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn't yet determined a price for the 28-pill packs. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.
A study showed Lybrel was just as effective in preventing pregnancy as a traditional pill, Alesse, also made by Wyeth. However, since Lybrel users will eliminate their regular periods, it may be difficult for them to recognize if they have become pregnant, Shames said.
Most of the roughly 12 million American women who take birth-control pills do so to prevent pregnancy. Others rely on hormonal contraceptives to curb acne or regulate their monthly periods.
Some nontraditional pills such as Yaz and Loestrin 24 shorten monthly periods to three days or less. Seasonique, an updated version of Seasonale, reduces them to four times a year. With Lybrel, in one test, 59 percent of the women who took Lybrel for a year had no bleeding or spotting during the last month of the study. However, because of dropouts, that translates into only about one-third of all the women originally enrolled in the study, Shames said.
"Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting," Shames said. The bleeding can last four to five days and may persist for a year, he later added. Women who take other low-dose pills have reported similar issues.
Still, a women's health expert said Lybrel would be a welcome addition for the woman who seeks relief from the headaches, tender breasts, cramps and nausea that can accompany monthly periods. Whether Lybrel relieves those symptoms was not directly studied.
"Over time she will experience markedly less bleeding episodes or no bleeding episodes," said Dr. Vanessa Cullins, vice president for medical affairs at
Planned Parenthood Federation of America Inc. "That is very beneficial for some women — and is wanted by some women."
University of New Hampshire sociologist Jean Elson pointed to advantages for what she characterized as a small number of women who suffer extraordinarily during menstruation, but overall she said the pill left her with mixed feelings.
"For women in that situation, I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event — not a medical condition," said Elson, who researches the sociology of gender and medical sociology. "Why medicate away a normal life event if we're not sure of the long-term effects?"
In recent years, as the hormone content of birth-control pills has dipped, failure rates have climbed. The FDA is considering whether to establish an acceptable failure rate for the pills. In January, a panel of agency advisers said less-effective birth-control pills should still merit federal approval if they promise other benefits, including improved safety.
Generally, lower-dose birth-control pills can reduce the risk of serious and sometimes deadly side effects, including blood clots and stroke, associated with their use.
The injectable hormonal contraceptive Depo-Provera also can eliminate monthly periods