Jeffrey Jensen, MD, reacts to FDA approval of new contraception patch, Gwyn Lo

The FDA's July 29, 2026 approval of norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris) adds a low-estrogen, once-weekly option to the combined hormonal contraception landscape, according to Jeffrey Jensen, MD, MPH, Professor, Obstetrics & Gynecology, Oregon Health & Science University. Full coverage of the approval is available here.¹

The patch was approved under the FDA's 505(b)(2) pathway for women with a body mass index (BMI) below 30 kg/m², delivering norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day interval, applied once weekly for 3 consecutive weeks followed by 1 patch-free week. In the phase 3 Luminous Study, the Pearl Index was 4.14 (95% CI: 2.77 to 5.95).

Jensen welcomed the approval as an expansion of choice for patients.

“More choices are always good. Patch users represent a small proportion of overall users of combined hormonal methods,” he said.

He noted practical considerations specific to a visible, wearable method, while emphasizing the value the patch offers.

“It is one thing if you are 60 and wearing a patch for chest pain, but harder when you are 17 and wearing a bikini. So I think that those are limitations for patches all around. That said, it provides a weekly option that has advantages for many users who want a non-daily routine,” Jensen said.

Jensen situated the product within a landscape that already includes the Xulane patch, and highlighted the reduction in synthetic estrogen.

“Reducing synthetic estrogens is a direction in the right way. It is the same basic EE concentrations that you would expect to see with the levonorgestrel patch. So nothing is really particularly innovative or different there,” he said, adding that he expects similar safety signals, contraindications, and BMI labeling.

On efficacy, Jensen said the reported Pearl Index aligns with contemporary United States evaluation standards.

“The Pearl Index they came up with is in line with the way methods are evaluated now in the [United States], and there has been lots written about that over the years about why Pearl indices are higher in the [United States] than Europe, and why they are different than they were 30 years ago. So none of that is surprising,” he said.

View Pearl index information for the patch here.

Per the approval, the patch is contraindicated in women with a BMI ≥30 kg/m² and in women who smoke and are over age 35.

Reference:

1. Fitch J. FDA approves norelgestromin and ethinyl estradiol transdermal patch for contraception. Contemporary OB/GYN. Published July 29, 2026. Accessed July 31, 2026. https://www.contemporaryobgyn.net/view/fda-approves-norelgestromin-ethinyl-estradiol-transdermal-patch-contraception