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Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

Viatris hopes to get FDA approval for a meloxicam formulation in acute pain (Shutterstock)

Viatris expects to file a fast-acting formulation of the established analgesic meloxicam (MR-107A-02) for US Food and Drug Administration approval during the second half of 2025, the company said during its first quarter sales and earnings call on 8 May. The filing is backed by data from two positive Phase III studies in post-surgical pain that show efficacy against both placebo and an opioid therapy comparator arm.

Key Takeaways
  • With Phase III success in two post-surgical pain settings, Viatris plans to seek US approval in acute pain for a meloxicam formulation acquired in 2018, the company said during its Q1 earnings call.

The Pittsburgh-based firm intends to seek FDA approval for the treatment of moderate-to-severe acute pain, chief research and development officer...

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