All Primary and Secondary Endpoints Were Met in Both Phase 3 Studies
In Both Acute Pain Models, MR-107A-02 Demonstrated Statistically Significant and Clinically Meaningful Improvement in Pain Compared to Placebo, Significant Reduction in Opioid Usage and Superior Pain Control Versus the Opioid Arm
Targeting New Drug Application Submission to U.S. FDA by End of 2025
PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results from its Phase 3 program of the novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain. The Phase 3 program consisted of two randomized, double-blind, placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy surgery (NCT06215859) and one following bunionectomy surgery (NCT06215820). Both trials evaluated the efficacy and safety of MR-107A-02 versus placebo and included an opioid comparator arm (tramadol 50mg q6h) to confirm the sensitivity of the pain model.
The primary endpoint in both trials was defined by the Sum of Pain Intensity Difference (SPID) based on the Numeric Rating Scale measured over 0-48 hours (SPID0-48h). Both trials evaluated the reduction in opioid usage that was defined by number of mean doses of opioid rescue medication and proportion of opioid-free patients over the combined in- and out-patient treatment phases.
In both studies, MR-107A-02 demonstrated statistically significant and clinically meaningful results. In particular:
- Treatment with MR-107A-02 led to improvement in pain versus baseline compared to placebo (herniorrhaphy: LS mean difference in SPID0-48h between MR-107A-02 and placebo = 50.1 (95% CI: 35.4, 64.8; p