Viatris Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Novel Fast-Acting Meloxicam (MR-107A-02) for the Treatment of Moderate-to-Severe Acute Pain

Core Insights - Viatris Inc. announced positive results from its Phase 3 trials for MR-107A-02, a fast-acting formulation of meloxicam, demonstrating significant pain relief compared to placebo and reduced opioid usage [1][2][3] - The company plans to submit a New Drug Application to the U.S. FDA by the end of 2025 based on these results [1][5] Group 1: Study Results - Both Phase 3 trials met primary endpoints, showing statistically significant and clinically meaningful improvement in pain management [2][4] - In the herniorrhaphy trial, the least squares mean difference in pain intensity (SPID0-48h) between MR-107A-02 and placebo was 50.1 (95% CI: 35.4, 64.8; p<0.001), while in the bunionectomy trial, it was 82.7 (95% CI: 62.0, 103.4; p<0.001) [4] - MR-107A-02 resulted in a higher percentage of opioid-free patients: 72.6% in herniorrhaphy versus 58.6% in placebo (p=0.002) and 56.9% in bunionectomy versus 33.1% in placebo (p<0.001) [4] Group 2: Efficacy and Safety - The treatment was well tolerated, with adverse events comparable to placebo, and no deaths reported [4] - The drug showed superior pain control compared to the opioid comparator (tramadol) in both surgical models, with faster onset of pain relief [4][3] Group 3: Future Plans - Viatris aims to present full results from the Phase 3 studies at upcoming conferences, including PAINWeek 2025 [5] - The company is building on previous Phase 2 data from dental pain studies to support its application for MR-107A-02 [5][10]