Viatris Secures FDA Approval For Gwyn Lo Contraceptive Patch
(RTTNews) - Viatris Inc. (VTRS) announced that the U.S. FDA has approved Gwyn Lo, a once-weekly combined hormonal contraceptive patch designed with a low dose of estrogen for women of childbearing potential with a body mass index below 30 kg/m².
Gwyn Lo delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day through a discreet transdermal system, offering a reversible, non-invasive option for contraception. The approval was supported by the Phase 3 Luminous Study, which demonstrated contraceptive efficacy, a well-characterized safety profile, and strong patch adhesion performance. The study reported a Pearl Index of 4.14 pregnancies per 100 woman- years of exposure in women aged 18 to 35 years.
Adhesion results showed only 1.3% of nearly 40,000 patches detached during the year-long trial, while common adverse reactions included application site irritation (4.8%), erythema (3.7%), intercycle bleeding (3.9%), heavy withdrawal bleeding (2.0%), and nausea (2.0%). Cycle control improved over time, with unscheduled bleeding rates dropping from 34.5% in Cycle 1 to 20% by Cycle 13. Additional Phase 1 studies confirmed consistent drug delivery under varied conditions including sauna, whirlpool, treadmill exercise and cold-water bath.
This approval marks a significant milestone in Viatris' women's health portfolio, expanding contraceptive options with a once-weekly patch that combines convenience, efficacy, and safety.
VTRS has traded between $8.63 and $17.94 over the past year. The stock closed Tuesday's trading at $17.86, up 1.28%. In pre-market trading the stock is at $17.96, up 0.56%.
