Viatris Reports Positive Phase 3 Results for Low-Dose Birth Control Patch, XULANE LO™

Hand holding a up a contraceptive patch NHS
News POSTED May 9, 2025 By CTI Exchange Staff

Viatris has announced successful Phase 3 trial results for its investigational low-dose birth control patch, XULANE LO™. The weekly patch, delivering 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily, met all primary and secondary efficacy and safety endpoints. 

Key findings from the study, which included over 1,200 participants across the U.S., Puerto Rico, and Canada, include: 

  • Pearl Index of 4.14, indicating strong contraceptive efficacy.
  • Cumulative pregnancy rate of 3.7% over 13 cycles.
  • Favorable safety profile, with most side effects rated mild to moderate.
  • Low rates of patch detachment (1.3%) and minimal skin irritation. 

Viatris plans to submit a New Drug Application to the FDA in the second half of 2025, positioning XULANE LO for women seeking a low-estrogen, reversible contraceptive method with convenient weekly dosing.