The US Food and Drug Administration has approved a norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo) for the prevention of pregnancy in women with a body mass index below 30 kg/m² who are appropriate candidates for combined hormonal contraception, according to a press release from Viatris.
The approval was supported by results from the phase 3 Luminous study, which evaluated contraceptive efficacy, safety profile, and patch adhesion. Among women aged 18 to 35 years in the efficacy-evaluable population, the Pearl Index, defined as the number of pregnancies per 100 woman-years of exposure, was 4.14.
Researchers reported complete patch detachment in 1.3% of the 39,790 transdermal systems applied during the year-long study. Additionally, four phase 1 studies demonstrated consistent drug delivery across multiple application sites and under conditions including sauna exposure, whirlpool use, treadmill exercise, and cold-water bathing.
The most common adverse reactions, occurring in at least 2% of patients, were application-site irritation, application-site erythema, application-site pruritus, intercycle bleeding, heavy withdrawal bleeding, and nausea. Researchers also reported that unscheduled bleeding or spotting decreased from 34.5% in cycle 1 to 20.0% by cycle 13, while the mean duration decreased from 3.2 days to 2.4 days.
The transdermal system delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day during each 7-day wear interval. According to the press release, patients apply one patch weekly for three consecutive weeks followed by one patch-free week.
According to data cited in the press release, unintended pregnancy accounted for 41.6% of pregnancies in the US in 2019. Viatris also cited a 2023 Centers for Disease Control and Prevention survey in which 18.1% of women who had used a contraceptive method reported changing or discontinuing their method within the previous 12 months, and 42.8% of those respondents reported disliking the contraceptive method they had been using.
Philippe Martin, chief research and development officer of Viatris, said in the press release, “Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen.”
According to the press release, Gwyn Lo is contraindicated in women who smoke and are older than 35 years because of an increased risk of serious cardiovascular events and in women with a body mass index of 30 kg/m² or greater. Viatris said the product is expected to become commercially available later this year.
Source: Viatris Inc.