U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain
The FDA has accepted Viatris' New Drug Application for MR-107A-02, a fast-acting oral formulation of meloxicam for moderate-to-severe acute pain. The submission is supported by two pivotal Phase 3 trials involving 989 post-surgical patients, which met primary and secondary endpoints for efficacy and safety while demonstrating reduced opioid usage.
Key figures
- Drug Name
- MR-107A-02 (fast-acting meloxicam)
- Phase Of Trial
- Phase 3
- Pdufa date
- Dec. 27, 2026
- Bunionectomy subjects
- 410
- Herniorrhaphy subjects
- 579
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