FDA sets Dec 27, 2026 deadline to review Viatris' fast-acting meloxicam for acute pain treatment

The FDA has accepted Viatris' New Drug Application for MR-107A-02, a fast-acting meloxicam designed to treat moderate-to-severe acute pain without opioids, setting a review deadline of December 27, 2026. This non-opioid treatment aims to address the significant public health need in the U.S., where acute pain affects over 80 million people annually and opioid use remains common. Phase 3 trials showed the drug's fast onset, strong pain relief, and reduced opioid use with a favorable safety profile. Viatris plans to continue developing value-added medicines like this to improve pain management options.