To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Birth Control Patch, Ortho Evra (Norelgestromin/Ethinyl Estradiol) URL: http://www.pslgroup.com/dg/20E3B2.htm Doctor's Guide November 21, 2001
RARITAN, NJ -- November 21, 2001 -- Ortho-McNeil Pharmaceutical, Inc., announced U.S. Food and Drug Administration (FDA) approval for the first birth control patch, Ortho Evra™. Approximately 38 million American women currently use some form of birth control. However, a recent national survey found that more than 75 percent of women say there is a need for methods that are more adaptable to their lifestyles(1).
Ortho Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progestin and estrogen, respectively) through the skin and into the bloodstream. Norelgestromin is the primary active metabolite of norgestimate -- the progestin used in the #1 prescribed birth control pill in the United States.
Ortho Evra is worn for one week at a time and is replaced on the same day of the week for three consecutive weeks. The fourth week is "patch-free." Women can wear Ortho Evra discreetly on one of four areas of the body: the buttocks, abdomen, upper torso (front and back, excluding the breasts), or upper outer arm. Studies show that Ortho Evra remains attached and effective while bathing, swimming, exercising or wearing it in humid conditions. In clinical studies, less than two percent of patches had to be replaced because of complete detachment and less than three percent had to be replaced because of partial detachment.
Phase III clinical trials involved more than 3,300 women for more than 22,000 menstrual cycles. One of these studies, which was published earlier this year in the Journal of the American Medical Association (JAMA), found that Ortho Evra was as effective in preventing pregnancy as a leading birth control pill.
Otho Evra will be available for prescription within the United States in the first half of 2002.
References:
1. The Women and OB/GYNs Speak Up Survey was conducted by Roper Starch and released by Ortho-McNeil Pharmaceutical and the American Medical Women's Association in November 2001
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