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Viatris Unveils Promising Phase 3 Results for XULANE LO Low Dose Patch

Viatris Inc., a leading global healthcare company, recently announced the positive results from its Phase 3 clinical trial evaluating the XULANE LO low dose weekly patch for contraception in women of childbearing potential. This innovative product, featuring a dosage of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day, demonstrated numerous benefits across multiple efficacy and safety endpoints during the study conducted across 81 investigative sites in the U.S., Puerto Rico, and Canada.

Study Overview

The Phase 3 study, denoted as NCT05139121, analyzed the patch's effectiveness in a cohort of 1,272 women aged between 16 and 35, maintaining a body mass index (BMI) of less than 30. The participants were evaluated over 13 consecutive 28-day cycles, amounting to a substantial dataset of 12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles. The primary efficacy endpoint indicated a Pearl Index (PI) of 4.14, signifying effective contraceptive outcomes among eligible women as well as a cumulative pregnancy probability of only 3.7% throughout the study duration.

Efficacy and Safety Findings

The XULANE LO patch displayed a favorable efficacy and tolerability profile, with over 80% of adverse events classified as mild to moderate. Specifically, it exhibited an impressive low rate of unscheduled bleeding and spotting events, affirming its reliability for users. Additionally, one of the standout features of the study was the patch's adhesion performance, with only 1.3% of patches completely detaching after a week of use and fewer than 1% of subjects experiencing severe local application site reactions. Such results suggest that the XULANE LO patch may set a new industry standard for hormonal contraceptive options.

Viatris Chief Research and Development Officer, Philippe Martin, remarked on the significance of these findings: "We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study. The data underscores our confidence in its potential to meet the unmet needs of women seeking a more manageable birth control method featuring lower estrogen dosage across a weekly application."

Future Steps

In light of these promising results, Viatris is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the latter half of 2025. Should the application be approved, the XULANE LO patch stands to make a significant impact on contraceptive options available to women everywhere.

About Viatris

Viatris is dedicated to providing extensive healthcare solutions globally, addressing a wide array of health needs by combining generic and branded pharmaceuticals into a unified portfolio. The company is prioritizing their mission to empower individuals worldwide to achieve a healthier lifestyle at any stage of life. As an innovative force in the healthcare industry, Viatris supplies high-quality medicines to nearly 1 billion patients annually, ensuring accessibility and availability of crucial medications across all corners of the globe.

Conclusion

The advances showcased in the XULANE LO trial reflect not only the effectiveness of the product but also the commitment of Viatris to meet the evolving demands for effective contraceptive measures. As further steps are undertaken in preparation for the NDA submission, stakeholders in healthcare and women's health will be keenly observing the reception of this pioneering approach to birth control.