Progestin-only ECPs on the way to the U.S.
With the first dedicated emergency contraceptive pills (ECPs) now on American market shelves, two companies are pursuing introduction of progestin-only pills for the same application.
Gynétics of Somerville, NJ, manufacturer of the Preven Emergency Contraceptive Kit, has begun multinational Phase III clinical trials on a levonorgestrel product, according to Ellyn Caravetta, a spokeswoman for the company. Prevent was the first dedicated combined hormonal EC product approved by the U.S. Food and Drug Administration (FDA). Approval of the levonorgestrel product in the United States and Canada is expected later this year or in early 2000.
Women’s Capital Corp., based in Seattle and Washington, DC, completed its New Drug Application in January for submission to the FDA, reports Sharon Camp, PhD, company president. "We hope to receive priority review status of six months or less, which would allow us to launch the product sometime this year," she says. "We expect to submit an application in Canada in the first part of this year."
The FDA has affirmed the safety and efficacy of the Yuzpe regimen for emergency contraception. The Preven kit follows the Yuzpe regimen, using four pills, each containing 0.05 mg ethinyl estradiol and 0.25 mg levonorgestrel. (Read more about the Preven kit and about progestin-only ECPs in Contraceptive Technology Update, November 1998, p. 141.)
Officials at Gynétics and Women’s Health Corp. are interested in pursuing dedicated progestin-only products after an international study last year demonstrated the advantages of a levonorgestrel-only emergency contraceptive over the Yuzpe regimen.
The study found that the levonorgestrel-only method was more effective and resulted in less nausea and vomiting than the combination regimen.1 The overall method failure rate (the percentage of women who became pregnant in spite of taking the treatment) was higher in the group using the Yuzpe regimen (3.2%) than in the progestin-only group (1.1%)
85% of pregnancies prevented
Calculations of the number of pregnancies that could have occurred if no treatment had been given showed the levonorgestrel method prevented 85% of unintended pregnancies, compared with 57% for the Yuzpe regimen. The trial was coordinated by the Special Programme of Research, Development, and Research Training in Human Reproduction, a division of the World Health Organization in Geneva, Switzerland.
"There are data on nearly 2,000 women in 21 study centers in 14 countries, including the U.S. and Canada, where we will market the product," Camp says about the study. "We are also providing supporting data from an earlier Hong Kong comparative study of over 840 women2 and 35 smaller clinical studies of levonorgestrel from postcoital contraception."
According to company officials, Gynétics plans to market the levonorgestrel pills with a step-by-step patient information book and a home pregnancy test. Women’s Health Corp. plans to market its product without a pregnancy test, says Camp.
The Preven kit is now available by prescription in more than 25,000 leading drug stores. The company anticipates Medical approval this month, with all states offering Medicaid reimbursement, except for Idaho and North Dakota.
Nearly 6,000 calls have been placed to the company’s toll-free number, 888-PREVEN2, and more than 500,000 "hits" have been recorded on the product’s Web site, www.PREVEN.com. The most frequented areas are pages reviewing the product insert, general product information, and general emergency contraception information.
More providers are getting the message on emergency contraception. The Association for Reproductive Health Professionals (ARHP) in Washington, DC, for example, is sponsoring a train-the-trainer program this year on the subject. (See box, above, for contact information.)
This large-scale pilot program, supported by a grant from the David and Lucile Packard Foundation in Los Altos, CA, is designed to raise emergency contraception awareness among local and regional clinical communities across the U.S. Trained faculty specialties will include physicians, nurse practitioners, physician assistants, nurse-midwives, pharmacists, and other health care professionals from all 50 states. Program partners include the Planned Parenthood Feder ation of America in New York City and the Reproductive Health Technologies Project in Washington, DC.
An expert advisory committee has developed a thorough program curriculum and is providing a core faculty of health care providers from every state with the tools to speak in a variety of venues, says Wayne Shields, ARHP president.
"This program is based on the assumption that learning is contextual and that an effective clinical training program addresses the realities of everyday life for American women and their health care providers," Shields states. "The curriculum offers core clinical essentials, alternative approaches, and information about related issues such as the legal environment and the media."
The Family Planning Association of Maine in Augusta used a grant from the John Merck Fund in Boston to provide training and education to physicians and midlevel providers in rural Maine on the uses, availability, and appropriateness of ECPs. Between 1996 and 1998, more than 500 providers received EC education, says Evelyn Kieltyka, head of program services.
The evaluation component of the project called for 2,389 anonymous surveys to be mailed in August 1996 to an assortment of physicians, nurse practitioners, and nurse-midwives, Kieltyka says. Eleven percent of them were returned. The same survey was mailed in June 1998, with a return rate of 23% — almost double the rate of the initial survey, she notes.
1. Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998; 352:428-33.
2. Ho PC, Kwan MSW. A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception. Hum Reprod 1993; 8:389-392.
For more on the emergency contraception "train the trainer" program, contact:
• Liz Callihan, Program Manager, Emergency Contraception Train-the-Trainer Program, Association of Reproductive Health Professionals, 2401 Pennsyl vania Ave. NW, Suite 350, Washington, DC 20037. Tele phone: (301) 320-8995. Fax: (202) 466-3826. E-mail: email@example.com.