Rx CARE

Birth control now comes in a patch for women

Choice appears to be the current mantra in contraception. And the Food & Drug Administration's recent approval of Ortho Evra (Ortho-McNeil Pharmaceuticals) offers women yet another choice. With Ortho Evra, the first transdermal contraceptive patch, dosing is once a week. In trials of more than 3,300 women for more than 22,000 menstrual cycles, the patch was both safe and effective, the company claims.

Patricia Stephenson, M.D., Stoneridge Obstetrics and Gynecology, Sellersville, Pa., an investigator in one of Ortho Evra's clinical trials, noted, "A couple of other [contraceptive] options have come out recently, but this is one of the better ones."

A randomized controlled clinical trial of 1,417 healthy women, published last May in the Journal of the American Medical Association, "found Ortho Evra to be as effective in preventing pregnancy as a leading birth control pill and that compliance ... was better with Ortho Evra than with the oral contraceptive comparator," stated Preeti Loomba, Pharm.D., Medical Information, Ortho-McNeil.

Ortho Evra releases 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream every 24 hours. The progestin in Ortho-Evra is norelgestromin, the primary active metabolite of norgestimate (the progestin in Ortho TriCyclen and Ortho-Cyclen).

Ortho Evra is formulated as a patch that is applied to healthy skin on the buttock, abdomen, upper outer arm, or upper torso. Stephenson remarked that participants "were really curious to see how well it would stick, what they could do to it to try to get it to unstick—part of the fun of being in the trial."

In clinical trials, the patches adhered well. "Less than 2% of patches were replaced because of complete detachment, less than 3% had to be replaced because of partial detachment," stated Loomba. She continued, "We also did a study that looked at patch wear under conditions of physical exertion, variable temperature and humidity, and less than 2% of patches were replaced because of complete or partial detachment in this study."

The patch is worn for seven days and replaced on day eight and 15. Day 22 begins a patch-free week. If the patch is not replaced on schedule and fewer than 48 hours elapse, a woman should remove the patch and apply a new patch immediately (no backup contraception is needed.) If more than 48 hours elapse, the recommendation is to start a new four-week cycle immediately by putting on a new patch. Because the woman may not be protected from pregnancy, an additional form of contraception is recommended for one week.

The most common adverse effects reported by 9%-22% of women using Ortho Evra in clinical trials were breast symptoms, headache, application site reaction, nausea, upper respiratory infection, menstrual cramps, and abdominal pain. Adverse effects common to oral contraceptives may also occur. According to Stephenson, "We did find some mild to moderate skin irritation, but it wasn't enough for people to discontinue the patch."

Ortho Evra is expected to be marketed in the first half of 2002. It will be priced competitively with other leading contraceptives. Whether other manufacturers will follow Ortho's lead in developing a contraceptive patch is unknown. Several companies have combination transdermal hormonal patches that are approved for use in women for symptoms of menopause or combination transdermal patches in their research pipelines; however, none would comment about the possibility of developing the transdermal hormonal technology for contraceptive use.

Yolanda Robles, a participant in the clinical trials, said she couldn't wait until Ortho Evra is marketed, because she considers it "so much easier to use than an oral contraceptive" and it simplifies her busy life.

Kathy Hitchens, Pharm.D.

The author is a clinical writer based in the Indianapolis area.

TIPS TO REMEMBER: Ortho Evra

• Clinical trials suggest Ortho Evra may be less effective in women weighing more than 198 lb.

• If a patch is not replaced within 48 hours of scheduled replacement, patients may not be protected from pregnancy and backup contraception should be used for seven days. Not more than seven patch-free days should elapse between cycles.

• A partially or completely detached patch should be replaced immediately, rather than "resticking."

• Ortho Evra does not protect against HIV or sexually transmitted diseases.

• The patch should be applied to clean, dry, intact healthy skin on the buttock, abdomen, upper outer arm, or upper torso, in a place where it won't be rubbed off by tight clothing.

• Ortho Evra should not be placed on skin that is red, irritated, or cut, nor should it be placed on the breasts.

• To prevent interference with the adhesive properties of Ortho Evra, no makeup, creams, lotions, powders, or other topical products should be applied to the skin area where the patch is or will be placed.

 

Kathy Hitchens. Birth control now comes in a patch for women. Drug Topics 2002;1:19.