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You might have to reformulate your response to patients’ request for the "acne pill" if the Food and Drug Administration (FDA) approves Philadelphia-based Wyeth-Ayerst Laboratories’ request to add an acne indication to its Alesse combined oral contraceptive (OC).
Wyeth-Ayerst has submitted a New Drug Application to the federal agency to receive an indication for use of the drug to "treat moderate acne vulgaris in women of reproductive age with no known contraindications to oral contraceptive therapy, who desire contraception, and are unresponsive to topical anti-acne medications."1 The data were accepted by the FDA in January 2001, according to a company press release.
Wyeth-Ayerst filed the request based on clinical data collected in trials intended to justify the indication, says Doug Petkus, a company spokesman.
"Other OCs manufacturers have the indication, so there are competitive and clinical reasons why we pursued it," states Petkus. If the new indication is approved, Alesse would be the first oral contraceptive containing 20 mcg of estrogen indicated for the treatment of acne.
Indication ups sales
Ortho Tri-Cyclen, marketed by Ortho-McNeil Pharmaceuticals of Raritan, NJ, has seen sales triple in a three-year span since it was approved in late 1996 for treatment of moderate acne vulgaris.2 (See Contraceptive Technology Update, March 1997, p. 25, for news of FDA’s approval.)
"Since February 1998, it’s been the most prescribed birth control pill in the U.S.," states Mark Monseau, an Ortho-McNeil spokesman. "In addition to being the only birth control pill clinically proven and approved by the FDA to help reduce moderate acne in women, it’s also well-tolerated and demonstrates excellent cycle control with low incidence of nuisance side effects."
Ortho Tri-Cyclen has enjoyed sustained popularity among providers, according to CTU’s annual Contraception Survey. Respondents to the 2000 poll named the pill as their first choice for 21-year-old nonsmoking women. Ortho Tri-Cyclen was the top choice in both formulary and nonformulary categories, with about 33% of survey respondents naming it as their first choice when not under formulary restrictions, and about 37% selecting it as the top choice in formulary plans. (See CTU, September 2000, p. 101, for complete survey results.)
However, the trend may be slipping, as both Alesse and another 20 mcg pill, Mircette (Organon, West Orange, NJ), moved up to capture more than 21% of top-choice selections in the 2000 survey. The two pills accounted for fewer than 10% of 1999 responses in the same category. (See CTU, June 2000, p. 72, for coverage of the increased popularity of 20 mcg pills.)
Data to be published
Alesse is a monophasic pill with 100 mcg levonorgestrel and 20 mcg ethinyl estradiol. Ortho Tri-Cyclen offers a steady dose of 35 mcg of ethinyl estradiol and a triphasic dose of norgestimate.
Efficacy data on Ortho Tri-Cyclen’s impact on acne vulgaris have been published.3,4
There are no published or presented data yet available on Alesse, says Petkus.
"The announcement we made is that the FDA accepted’ our data submission, and now they are reviewing the information," he states. "Once they render a final decision, we will be able to share the clinical data they are currently evaluating."
A 2000 survey published by the Washington, DC-based American College of Obstetricians and Gynecologists shows more women are starting to rely on the Pill for its noncontraceptive benefits.5 Acne treatment and regulation of menstrual periods were the two benefits listed most frequently by survey respondents.
Oral contraceptives have proven to be an excellent option for pregnancy prevention, but they also offer many important noncontraceptive health benefits for the women who use them, notes Wayne Shields, president and CEO of the Wash-ington, DC-based Association of Reproductive Health Professionals (ARHP). Those health benefits include reduced risk of some reproductive cancers and beneficial effects on fibroids.
"ARHP supports the efforts of pharmaceutical companies to study noncontraceptive health benefits of OCs — and other hormonal methods as well," Shields comments. "This positive action can raise the standard of health care for women by helping us better understand the benefits and risks associated with OC use."
1. Wyeth-Ayerst Laboratories. Wyeth-Ayerst Laboratories NDA for New Indication for Alesse Accepted by FDA. St. Davids, PA: Jan. 18, 2001.
2. Associated Press. Demand for the pill’ increases to fight acne. Jan. 31, 2000. Web: www.thehollandsentinel.net/stories/ 013100/new_demand.html.
3. Redmond GP, Olson WH, Lippman JS, et al. Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: A randomized, placebo-controlled trial. Obstet Gynecol 1997; 89:615-622.
4. Lucky AW, Henderson TA, Olson WH, et al. Effective-ness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris. J Am Acad Dermatol 1997; 37(5 Pt 1):746-754.
5. American College of Obstetricians and Gynecologists. Women more comfortable with pill use. ACOG 2000; 7:1.