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The FDA has approved Gwyn Lo (Viatris), a new birth control patch that uses low-dose estrogen to prevent pregnancy.
The patch is designed for once-weekly administration and delivers the hormones norelgestromin (220 μg/day) and ethinyl estradiol (20 μg/day) directly through the skin. It is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.
Gwyn Lo is approved for women with a BMI below 30 who are appropriate candidates for combined hormonal contraceptives, according to a release from Viatris.
The approval was supported by results from a phase 3 clinical trial that evaluated the patch's contraceptive efficacy, safety profile, and adhesion performance. Researchers measured the contraceptive effectiveness using the Pearl Index, which reflects the number of pregnancies per 100 woman-years of use. The Pearl Index was 4.14 (95% CI, 2.77-5.95) among women ages 18-35.
The patch showed strong adhesion in real-world conditions during the year-long trial, with only 1.3% of the 39,790 patches applied over the trial fully detaching.
The most common side effects were application-site irritation (4.8%), redness (3.7%), itching (3.7%), intercycle bleeding (3.9%), heavy withdrawal bleeding (2%), and nausea (2%).
The rate of unscheduled bleeding or spotting decreased over time, from 34.5% in the first cycle to 20% by cycle 13.
Women who smoke and are older than 35 should not use Gwyn Lo, as there is a risk for heart and blood vessel complications. Women with a BMI of 30 or higher may have an increased risk for blood clots. Patients should speak with a healthcare provider about their medical history and risk factors before using Gwyn Lo.
Gwyn Lo is expected to become available commercially later this year, according to the release.
