PR Newswire·May 18, 2026, 8:00 AM ET

U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain

Viatris Inc. announced that the FDA accepted the New Drug Application for MR-107A-02 (fast-acting meloxicam) to treat moderate-to-severe acute pain.
The FDA assigned a PDUFA goal date of December 27, 2026, for the review of this non-opioid investigational drug.
MR-107A-02 is an oral formulation of meloxicam designed for rapid dissolution & absorption compared to currently approved products.
The application relies on Phase 3 data from two randomized trials following herniorrhaphy surgery (NCT06215859) & bunionectomy surgery (NCT06215820).
Both trials met primary & secondary endpoints, demonstrating strong analgesic efficacy, a fast onset of action, & a significant reduction in opioid usage versus placebo.
The studies included an opioid arm using tramadol to confirm the sensitivity of the pain model & evaluated safety over 0-48 hours inpatient & outpatient phases.
Over 80 million individuals in the U.S. experience acute pain annually, with more than half of surgical patients reporting inadequate pain relief despite opioid use.
Viatris submitted the NDA under the 505(b)(2) regulatory pathway, & the product remains unapproved by any regulatory authority as of May 18, 2026.