FDA Accepts Viatris' Application for Fast-Acting Meloxicam to Address Acute Pain
The U.S. Food and Drug Administration (FDA) has accepted Viatris Inc.'s New Drug Application for a fast-acting formulation of meloxicam, a non-opioid treatment for moderate-to-severe acute pain. This development marks a significant step towards providing a non-opioid alternative for pain management, addressing a critical public health need in the United States. Acute pain, often resulting from surgery or trauma, affects over 80 million Americans annually and is a major reason for emergency department visits. The new formulation, MR-107A-02, has shown promising results in Phase 3 trials, demonstrating rapid onset and sustained analgesic efficacy, with a notable reduction in opioid usage. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for December 27, 2026, to complete its review. 
