The FDA’s approval of norelgestromin and ethinyl estradiol transdermal system, also known as Gwyn Lo, adds a new option to the combined hormonal contraception market. Jeffrey Jensen, MD, MPH, Professor of Obstetrics & Gynecology at Oregon Health & Science University, notes that this approval provides a low-estrogen, once-weekly option for women.
The patch was approved under the FDA’s 505(b)(2) pathway for women with a body mass index (BMI) below 30 kg/m². It delivers 220 mcg/day of norelgestromin and 20 mcg/day of ethinyl estradiol over each 7-day interval, applied once weekly for 3 consecutive weeks followed by 1 patch-free week.
Approval Details
In the phase 3 Luminous Study, the Pearl Index was 4.14 (95% CI: 2.77 to 5.95). Jeffrey Jensen welcomed the approval, stating that more choices are always good for patients.
“More choices are always good. Patch users represent a small proportion of overall users of combined hormonal methods,” he said. Jensen also noted practical considerations specific to a visible, wearable method, while emphasizing the value the patch offers.
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“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.
Comparison to Existing Products
Jensen situated the product within a setting 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.
Jensen expects similar safety signals, contraindications, and BMI labeling. On efficacy, Jensen said the reported Pearl Index aligns with contemporary United States evaluation standards.
The patch is contraindicated in women with a BMI ≥30 kg/m² and in women who smoke and are over age 35. According to the report, this approval provides a new option for women seeking a low-estrogen, once-weekly contraceptive method.
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Safety and Efficacy
The FDA approval of the patch marks a significant development in the field of contraception. As Jensen notes, the reduction in synthetic estrogens is a step in the right direction.
In the context of the existing contraceptive market, this approval offers women more choices and flexibility in their reproductive health decisions. The patch’s weekly application and low-estrogen formula may appeal to women seeking a convenient and relatively low-maintenance contraceptive option.
As the market continues to evolve, it’s likely that we’ll see more innovations in contraceptive technology. For now, the approval of Gwyn Lo provides a new option for women seeking a reliable and effective form of birth control.
