|For Immediate Release||Roderick L. Mackenzie|
-- Important Contraceptive Option Could Potentially Reduce Abortions and Unintended Pregnancies By Half --
SOMERVILLE, NJ, September 2, 1998 -- Gynétics Inc. announced today that the Food and Drug Administration (FDA) has approved the PREVENTM Emergency Contraceptive Kit. This is the first FDA-approved product for emergency contraception that can prevent pregnancy when used within 72 hours (three days) after sex. The PREVENTM Emergency Contraceptive Kit, which will be available by prescription from doctors and other healthcare professionals before the end of September, is made in the United States.
The PREVENTM Emergency Contraceptive Kit pill regimen is the most widely studied and used emergency contraceptive. The regimen utilizes special doses of regular birth control pills, which act before pregnancy begins and will not affect an existing pregnancy. Used correctly, the pills in the PREVENTM Kit may result in only about two out of 100 women becoming pregnant after an act of sex.
"It is estimated that nearly 50 percent of all abortions and unintended pregnancies in this country could be avoided if women had access to emergency contraception"," said Anita Nelson, MD, Associate Professor in the Department of Obstetrics and Gynecology at the University of California at Los Angeles. "The availability of an effective emergency contraceptive option with a good safety profile is a major milestone in women's reproductive health. Women may want to discuss keeping the PREVENTM Kit on hand with their doctors or other healthcare professionals in case emergency contraception becomes necessary."
There are over 2.7 million unintended pregnancies per year in the United States; nearly half are due to contraceptive failure. According to the Centers for Disease Control and Prevention (CDC), more than 11 million American women report using contraceptive methods associated with high failure rates, including condoms, withdrawal, periodic abstinence and diaphragms. These facts led the FDA to request that Gynétics make an emergency contraceptive product available in the United States.
The PREVENTM Emergency Contraceptive Kit has three easy steps that set a new standard of care in emergency contraceptive therapy: a step-by-step "Patient Information Book" with detailed patient information, a pregnancy test and four light blue birth control pills. The pills in the PREVENTM Emergency Contraceptive Kit contain progestin (0.25mg levonorgestrel) and estrogen (0.05mg ethinyl estradiol).
"Taking the pregnancy test is an important step when using emergency contraceptive pills", said Dr. Nelson. "Determining that a pregnancy has not taken place from sex earlier in the month or in previous months helps ensure that the pills in the PREVENTM Kit have an opportunity to work.* If a woman learns she is pregnant, she should visit a doctor or other healthcare professional as soon as possible."
"The only definitive scientific evidence indicates that the birth control pills in the PREVENTM Emergency Contraceptive Kit work by preventing or delaying ovulation. It has been theorized that birth control pills may also prevent fertilization of an egg, if one has been released from the ovary, or that they may produce changes in the lining of the uterus that could prevent implantation of a fertilized egg", said Carolyn Westhoff, MD, Associate Professor of Clinical Obstetrics and Gynecology and Public Health at Columbia University. "The pills will not work if a woman is already pregnant and will not affect a pregnancy."
Emergency contraceptive pills have sometimes been referred to as "morning after" pills. This is misleading since they can, in fact, be taken up to 72 hours (three days) after sex, not just the morning after. The pills in the PREVENTM Emergency Contraceptive Kit work before pregnancy or conception begins and should not be confused with RU486, the "abortion pill".
After a woman determines that she is not pregnant by using the pregnancy test included in the PREVENTM Kit, the first dose of two light blue emergency contraceptive pills is taken, as soon as possible, within 72 hours (three days) after sex with a known or suspected birth control failure or after sex without birth control. The second dose is taken 12 hours later.
"We are pleased to meet an important contraceptive need", said Roderick L. Mackenzie, Gynétics' Chairman and Founder. "The PREVENTM Emergency Contraceptive Kit demonstrates Gynétics' leadership and commitment to women's reproductive health", added Mackenzie, who is also a past President of Ortho Pharmaceutical Corporation and the founder of GynoPharma Inc., a women's healthcare company. The product is made in the United States exclusively for Gynétics.
Recognizing the need for emergency contraception, the FDA, on February 25, 1997, issued a statement in the Federal Register that emergency contraceptive pills were "safe and effective" in preventing pregnancy after sex.
The FDA based its support of emergency contraception on a meta-analysis of 10 emergency contraceptive pill studies with special doses of regular birth control pills. These studies, conducted since 1977, showed a good safety profile. The most commonly reported side effects were nausea and/or vomiting that may last a few hours or up to one to two days.
Other side effects may occur, some of which can be serious. To find out if emergency contraceptive pills are right for them, women should discuss the use of emergency contraception with their doctors or nurse practitioners, or with other healthcare professionals at family planning clinics. Like all birth control pills, emergency contraceptive pills do not protect against infection with HIV (the virus that causes AIDS) and other sexually transmitted diseases.
Gynétics Inc. is a privately-held women's healthcare company based in New Jersey. Gynétics was founded in 1995 to develop and market pharmaceutical products and medical devices to advance the healthcare of women. Gynétics also markets the GynoSampler(r) Endometrial Curette, an endometrial sampling device used by physicians.
To help address questions about the PREVENTM Emergency Contraceptive Kit and emergency contraception, Gynétics has established a toll-free number (1-888-PREVEN2) and web site (www.PREVEN.com) for women and healthcare professionals.
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