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Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints Results Demonstrated Potential Best-In-Class Patch
About this update from Viatris Inc.
[{"type":"text","content":"Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints\nResults Demonstrated Potential Best-In-Class Patch Performance \nNew Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025\nPITTSBURGH, 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.\nIn 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:\nWith a Pearl Index (PI) of 4.14, the study demonstrated contraceptive efficacy. This primary efficacy endpoint was measured in eligible women aged 16 to 35 with a body mass index","length":1910,"tagName":"div"}]