For Immediate Release:
February 3, 1999
For more information:
Pamela Long (206) 223-6338
Washington, D.C. - Women's Capital Corporation (WCC) announced today that it has completed a New Drug Application for a progestin-only emergency contraceptive. The NDA was submitted to the Food and Drug Administration (FDA) on January 29. WCC hopes for a priority review, which could result in product approval within the next six months.
The "second generation" product, which consists of two 0.75 mg tablets of levonorgestrel, is manufactured in Europe. Levonorgestrel has been used for postcoital contraception in Europe for almost 20 years. The WCC product is based on a new regimen, recently tested in almost 2,000 women in 14 countries. Half of the women in the 21-center study took the older emergency contraceptive regimen of high-dose oral contraceptives containing estrogen and progestin; the other half took the progestin-only regimen. The larger study was designed to confirm the results of a 1993 Hong Kong study of 834 women that also compared the two regimens.
"Although some women will experience mild side effects, such as nausea, I believe the new progestin-only emergency contraceptive will be readily accepted by both health care providers and their clients," said Dr. Edith Guilbert, a Canadian physician who took part in the most recent study. "Now our challenge is to increase awareness of emergency contraception, and to let women know that they still have options for preventing an unintended pregnancy after a contraceptive accident."
The new study, results of which were published in Lancet August, 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 the Hong Kong study and three other multicenter studies of the levonorgestrel tablet.
According to Dr. Sharon Camp, President of WCC, the Application for the new product includes published and unpublished clinical data on nearly 15,700 women who have used levonorgestrel after sex to prevent pregnancy. Levonorgestrel has been a component of daily birth control pills since 1968, and is used in nearly 150 brands of pills sold internationally.
Camp contends that, like older "morning-after" regimens, the new levonorgestrel regimen acts to prevent pregnancy, but cannot cause abortion. The pills are thought to work most of the time prior to fertilization. They are not at all effective once a fertilized egg has implanted in the womb.
WCC's effort to develop and market the new product represents 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 the new venture 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.
Women's Capital Corporation is a privately held company, organized in 1997, to bring the new emergency contraceptive product to the U.S. and Canadian markets, and to develop other critically-needed reproductive health products for women.
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