Full Press Release Details
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints
Results Demonstrated Potential Best-In-Class Patch Performance
New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025
PITTSBURGH , May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS ), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential. The study evaluated women of childbearing potential (N=1,272) for up to 13 cycles (12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles) across 81 investigative sites throughout the U.S., Puerto Rico and Canada .
In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. In particular:
"We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study," said Viatris Chief R&D Officer Philippe Martin . "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 with potential best-in-class adhesion performance."
The Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2025.
About the Phase 3 Study Design (NCT05139121) The multicenter, open-label, single-arm study, evaluated the contraceptive efficacy of investigational XULANE LO low dose patch when used over thirteen 28-day cycles in 1,272 healthy, post-menarcheal, pre-menopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age.
About Viatris Viatris Inc. (Nasdaq: VTRS ) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India . Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X (formerly Twitter).
SOURCE Viatris Inc.