Women's Capital Corporation
PO Box 5026
Bellevue, WA 98008
For Immediate Release: July 28, 1999For More Information:
A NEW GENERATION OF EMERGENCY CONTRACEPTION HAS ARRIVED
FDA Approves Progestin-only Emergency Contraceptive,
Plan BTM (levonorgestrel) tablets
Washington, D.C. - The FDA today approved Plan B, the first progestin-only pill developed to prevent pregnancy after a contraceptive accident or unprotected sex. The new product is highly effective and produces much less nausea and vomiting than other emergency contraceptive pills.
The small Plan B package (about the size of a woman's compact) consists of two 0.75 mg tablets of levonorgestrel. The first pill needs to be taken within 72 hours of unprotected sex. The second pill is taken 12 hours later.
"Levonorgestrel has been one of the synthetic hormones used in daily birth control pills since 1968. It's a component in over 80 brands of pills sold internationally," said Sharon Camp, Ph.D., President of Women's Capital Corporation (WCC), the U.S. distributor for Plan B. "We are really excited to be able to provide this important advance in emergency contraception to American women."
According to the FDA-approved labeling for the product, "Plan B demonstrated a superior safety profile" over the 25-year old Yuzpe regimen for nausea and vomiting. Nausea occurs in 23.1 percent of women taking Plan B (compared to 50.5 percent with Yuzpe). Vomiting occurs in 5.6 percent of women taking Plan B (compared to 18.8 percent with Yuzpe). Other side effects include abdominal pain (17.6 percent), fatigue (16.9 percent), headache (16.8 percent), heavier (13.8 percent) or lighter (12.5 percent) menstrual bleeding, dizziness (11.2 percent), and breast tenderness (10.7 percent).
Plan B reduces the risk of pregnancy from about eight percent down to one percent. This represents an 89 percent reduction in risk of pregnancy following a single act of unprotected sex. Efficacy is better if Plan B is taken as directed as soon as possible after unprotected intercourse.
Plan B is not effective if a woman is already pregnant and will not terminate an existing pregnancy. Plan B is believed to act as an emergency contraceptive mainly by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.
Plan B should not be used as a routine form of contraception. It is less effective than most regular contraceptives and does not protect against sexually transmitted diseases.
The Plan B regimen was tested by the World Health Organization (WHO) in almost 3,000 women in 15 countries, including the United States and Canada. Half of the women in a large, 21-center study, took the older, so-called, Yuzpe emergency contraceptive regimen. The Yuzpe regimen (sometimes referred to as the morning-after pill) involves two high doses of oral contraceptives containing estrogen and progestin. Prior to FDA approval of Plan B, most emergency contraceptive regimens available in the United States were based on the Yuzpe regimen.
"I believe the new progestin-only emergency contraceptive will be readily accepted by health care providers in both the United States and Canada," said Dr. Edith Guilbert, a leading Canadian physician who took part in the most recent WHO study. "Plan B will be much easier to administer and use than the older regimens. A new and better product will also help increase awareness of emergency contraception and this should help reduce high rates of unintended pregnancy significantly in both the United States and Canada."
The WHO study, results of which were published in the Lancet (August 8, 1998), was sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction (WHO/HRP), a program set up in 1972 by the World Health Organization to coordinate international efforts on priority research leads. WHO/HRP also supported a 1993 Hong Kong study that compared the two regimens, and three other multicenter studies of the levonorgestrel tablet for use as ongoing postcoital contraception. Results from the two studies on emergency contraception indicated that Plan B is highly effective and much better tolerated than the older Yuzpe regimen.
Initially, Plan B will be available by prescription through Planned Parenthood clinics and other health care providers listed on the 24-hour Emergency Contraception Hotline (1-888-NOT-2-LATE) and the Emergency Contraception Web site (http://www.princeton.edu/ec/). Washington State pharmacists with prescriptive authority for emergency contraceptive pills will also have access to Plan B during the initial launch phase. Later in 1999, WCC expects to make Plan B available to all market segments nationwide.
WCC is a privately held company, organized in 1997, to bring Plan B to the U.S. and Canadian markets, and to develop other critically-needed reproductive health products for women. WCC's efforts to develop and market Plan B represent a novel public/private sector partnership, involving not-for-profit organizations, such as the Seattle-based Program for Appropriate Technology in Health, which pioneered pharmacists' prescriptive authority for emergency contraception in Washington State. Financing for Plan B has come, in large part, from U.S. foundations, such as the David and Lucile Packard Foundation, the Wallace Alexander Gerbode Foundation, and the Compton Foundation. Robert Wallace, Chairman of the Wallace Global Fund, was the project's "angel investor". Five Planned Parenthood affiliates also made equity investments in Plan B, including Planned Parenthood of Western Washington.
For more information about Plan B, please access the Plan B Web site at http://www.go2planb.com.
Anyone who can dispense Plan B can order the product by phone (1-800-330-1271) or fax (1-973-822-1444). The product will not be available in retail pharmacies until later this year.