Viatris Announces Promising Results from Phase 3 Study
Treatment with the XULANE LO low estrogen dose patch has achieved all primary and secondary efficacy and safety endpoints. Results suggest a potentially best-in-class patch performance.
The company anticipates submitting a New Drug Application to the U.S. FDA in the second half of 2025.
Viatris Inc., a leading healthcare organization, recently shared encouraging results from its Phase 3 study, designated NCT05139121. The trial assessed the contraceptive efficacy and safety of the investigational XULANE LO low-dose patch, which delivers 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily to women of childbearing potential.
Involving 1,272 participants, the study assessed performance over a maximum of thirteen 28-day cycles, covering 12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles. Sites across a wide region were engaged, ensuring comprehensive data collection.
Key Findings from the Study
The findings indicated that the XULANE LO patch showed a solid efficacy profile with no significant safety concerns. Specific details include:
- The Pearl Index (PI) was calculated at 4.14, showcasing effective contraception. This measurement was observed in eligible women aged 16 to 35 with a body mass index under 30.
- A cumulative pregnancy probability over the examined cycles stood at 3.7%, indicating effective birth control throughout the study.
- The safety profile was favorable, with treatment-related adverse events primarily classified as mild to moderate. Low instances of unscheduled bleeding and spotting were also reported, suggesting good cycle control.
- Most remarkably, patch adhesion was excellent, with only 1.3% of patches completely detaching during the seven-day wear period, assuring users of reliable application.
Philippe Martin, the Chief R&D Officer at Viatris, expressed satisfaction with the study's results, focusing on the importance of offering a product that caters to women's needs in reversible birth control. According to Martin, the data strongly supports the viability of the XULANE LO patch as a lower-dose estrogen option with commendable adhesion features.
Study Design Overview
The multicenter, open-label, single-arm study aimed to ascertain how effectively the investigational XULANE LO patch functions in delivering contraception across its designated cycles. Eligible participants were female subjects of childbearing potential, post-menarcheal, pre-menopausal, and heterosexually active, starting from the age of 16.
About Viatris
Viatris Inc. is uniquely positioned in the global healthcare landscape, blending generics and branded medicines to meet a wide array of healthcare needs. Aiming to empower individuals globally for healthier lives, Viatris is committed to providing access to quality medicines for nearly a billion patients yearly, addressing health challenges from the beginning to the end of life.
The company operates on a massive scale, with an extensive portfolio and an innovative global supply chain that ensures medicines reach those who need them. Headquartered in the U.S., Viatris collaborates with healthcare organizations worldwide to impact significant health outcomes.
Frequently Asked Questions
What is the main focus of the study conducted by Viatris?
The primary focus of the study is to evaluate the contraceptive efficacy and safety of the XULANE LO low-dose patch in women of childbearing potential.
What were the key results of the Phase 3 study for XULANE LO?
The study showed effective contraceptive efficacy with a Pearl Index of 4.14 and a cumulative pregnancy probability of 3.7% over 13 cycles.
When does Viatris plan to submit the New Drug Application?
Viatris anticipates submitting the New Drug Application to the FDA in the second half of 2025.
What notable safety findings emerged from the study?
The safety profile was favorable, with most treatment emergent adverse events reported as mild to moderate, and low instances of unscheduled bleeding were noted.
How does the XULANE LO compare with existing contraceptive methods?
With its lower estrogen dosage and promising adhesion performance, XULANE LO aims to be a leading option among reversible contraceptive methods.
