Viatris Inc. announced positive results from its Phase 3 clinical trial evaluating XULANE LO, a low-dose contraceptive patch designed to deliver 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol daily. The study met its primary and all secondary efficacy and safety endpoints, positioning the product as a potential new option for women seeking hormonal contraception with reduced estrogen exposure.
The multicenter, open-label, single-arm study enrolled 1,272 women of childbearing potential across 81 investigative sites in the United States, Puerto Rico, and Canada. Participants used the weekly dermal patch for up to 13 menstrual cycles, generating 12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles.
Efficacy and Safety Profile
The trial's primary efficacy endpoint was measured using the Pearl Index (PI), a standard metric for contraceptive effectiveness that calculates the number of pregnancies per 100 woman-years of use. XULANE LO achieved a PI of 4.14 in eligible women aged 16 to 35 with a body mass index below 30 kg/m². Additionally, the cumulative probability of pregnancy over the 13-cycle study period was 3.7%.
"These results demonstrate that XULANE LO provides effective contraception while delivering a lower dose of estrogen compared to other available patch options," said Philippe Martin, Chief R&D Officer at Viatris. "The data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch."
Safety data revealed a favorable tolerability profile, with most treatment-emergent adverse events (TEAEs) categorized as mild to moderate in severity. The study also showed favorable cycle control with generally low rates of unscheduled bleeding and spotting events, which are important considerations for user satisfaction and adherence.
Superior Patch Performance
A notable finding from the study was the patch's exceptional adhesion properties. Only 1.3% of patches completely detached during the seven-day wearing period, and fewer than 1% of subjects reported severe local application site reactions. This performance characteristic could represent a significant advantage over existing contraceptive patches, which sometimes face challenges with adhesion in real-world use.
"The adhesion profile demonstrated in this study is particularly encouraging," noted Martin. "For a contraceptive patch to be effective, it must reliably adhere to the skin throughout the wearing period. The low detachment rate observed with XULANE LO suggests potential best-in-class performance in this critical aspect."
Addressing Unmet Needs in Contraception
Hormonal contraceptives containing estrogen have been associated with various side effects and risks that increase with higher hormone doses. By developing a lower-dose option, Viatris aims to provide women with a contraceptive that maintains efficacy while potentially reducing estrogen-related side effects.
The weekly application schedule of XULANE LO offers an alternative to daily oral contraceptives, which require consistent daily adherence. This may be particularly beneficial for women who struggle with daily pill regimens or prefer a less frequent dosing schedule.
Regulatory Timeline
Based on these positive Phase 3 results, Viatris plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2025. If approved, XULANE LO would join the company's existing women's health portfolio.
Study Design Details
The Phase 3 trial (NCT05139121) was designed as a multicenter, open-label, single-arm study evaluating contraceptive efficacy when used over thirteen 28-day cycles. Eligible participants included healthy, post-menarcheal, pre-menopausal, heterosexually active females of childbearing potential who were at least 16 years of age.
The study design follows standard protocols for contraceptive efficacy trials, allowing for comparison with other hormonal contraceptive methods. The 13-cycle duration provides sufficient data to assess both short-term efficacy and safety, as well as patterns of use over approximately one year.
Market Context
The contraceptive market continues to evolve as manufacturers develop products that address women's preferences for convenience, reduced side effects, and reliability. Transdermal delivery systems like contraceptive patches offer advantages of weekly versus daily administration while maintaining hormone levels more consistently than oral contraceptives.
If approved, XULANE LO would enter a market where options for non-daily hormonal contraception include vaginal rings, injections, implants, intrauterine devices, and other patches. The potential advantages of XULANE LO's lower estrogen dose and superior adhesion could differentiate it within this competitive landscape.
