FDA approves norelgestromin and ethinyl estradiol transdermal patch for contraception

On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.¹

The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).² Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.¹

According to Viatris, unintended pregnancy accounted for 41.6% of pregnancies in the United States in 2019. A 2023 survey from the Centers for Disease Control and Prevention found that 18.1% of women who had used a contraceptive method changed or stopped it within the previous 12 months, and of those, 42.8% reported not liking the method they had been using.³

“[Norelgestromin and ethinyl estradiol transdermal system] will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen," said Philippe Martin, R&D officer, Viatris, in a statement. “This includes demonstrated efficacy in women with a BMI of 25 to less than 30 kg/m², with no BMI-based limitation of use in this population."¹

Phase 3 Luminous Study of Gwyn Lo

The primary efficacy endpoint in the Luminous Study was the Pearl Index (PI), defined as the number of pregnancies per 100 woman-years of exposure in the efficacy evaluable population of women aged 18 to 35 years. The PI was 4.14 (95% CI: 2.77 to 5.95).

The study also demonstrated patch adhesion under real-world conditions, as 1.3% of the 39,790 transdermal systems applied during the year-long trial fully detached. Data from 4 phase 1 studies investigating various application sites and conditions demonstrated consistent drug delivery under conditions including sauna, whirlpool, treadmill exercise, and cold-water bath.

Cycle control improved over the course of the study, with rates and duration of unscheduled bleeding or spotting decreasing from 34.5% and a mean of 3.2 days in Cycle 1 to 20.0% and 2.4 days by Cycle 13.

What are the most common adverse reactions?

The most common adverse reactions reported in 2% or more of participants during the Luminous Study were:

• Application site irritation (4.8%)
• Intercycle bleeding (3.9%)
• Application site erythema (3.7%)
• Application site pruritus (3.7%)
• Heavy withdrawal bleeding (2.0%)
• Nausea (2.0%)

Norelgestromin and ethinyl estradiol is indicated for prevention of pregnancy in women with a BMI below 30 kg/m² for whom a CHC is appropriate. The product is contraindicated in women who smoke and are over 35 years of age due to an increased risk of serious cardiovascular events. The patch is also contraindicated in women with a BMI ≥ 30 kg/m², as venous thromboembolism risk could be greater with the patch in women with this higher BMI compared to those with a lower index.

Additionally, the label reflects demonstrated contraceptive efficacy in women with a BMI of 25 to less than 30 kg/m², with no BMI-based limitation of use in this population.

When will the patch be available?

Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.

References:

1. Viatris Receives U.S. FDA Approval for Gwyn Lo™, a Once-Weekly Contraceptive Patch. Viatris. News release. Published July 29, 2026. Accessed July 29, 2026. https://prnmedia.prnewswire.com/news-releases/viatris-receives-us-fda-approval-for-gwyn-lo-a-once-weekly-contraceptive-patch-302837674.html
2. Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles. ClinicalTrials.gov. Updated January 28, 2025. Accessed July 29, 2026. https://clinicaltrials.gov/study/NCT05139121
3. NCHS Rapid Survey System. CDC. Accessed July 29, 2026. https://www.cdc.gov/nchs/rss/round2/contraception-use.html