Viatris Announces FDA Acceptance of NDA for Fast-Acting Meloxicam in Acute Pain Treatment

Viatris Inc., a global healthcare provider, announced that the U.S. Food and Drug Administration will review its New Drug Application (NDA) for MR-107A-02, a non-opioid medication for the treatment of moderate-to-severe acute pain. The goal date added by the FDA to PDUFA is Dec. 27, 2026. In the U.S., more than 80 million people suffer from acute pain annually, and opioids are prescribed to manage acute pain.

Advancing Non-Opioid Pain Management 

The NDA data are based on Viatris two double-blind, randomised, placebo-controlled, and active-comparator-supported Phase 3 studies of the company in patients undergoing herniorrhaphy and bunionectomy, respectively. The primary endpoint in both trials was pain intensity 48 hours after the first treatment, and both fast-time meloxicam groups were able to achieve the primary endpoint compared to placebo. 

The U.S. FDA's acceptance of an NDA for the investigational, fast-acting meloxicam is a significant milestone in bringing a potential new first-line pain treatment to people with moderate to severe acute pain who require treatment in the U.S., said Philippe Martin, M.D., M.P.Phil., Chief R&D Officer, Viatris. 

According to Precedence Research, the U.S. Pain Management Drugs Market size was calculated at USD 32.79 billion in 2025 and is predicted to increase from USD 33.84 billion in 2026 to approximately USD 46.50 billion by 2035, expanding at a CAGR of 3.56% from 2026 to 2035, driven by rising demands for efficient nonopioid therapies, advances in drug development, and continuous efforts in countering opioid dependence. 

Industry Impact and Outlook

The recently submitted application from Viatris and its FDA approval underscore an increased focus in the pharmaceutical field on alternative treatments for pain besides opioids. Fast-acting meloxicam could be an alternative drug of first choice for their acute pain if both doctors and patients are not able to use opioids. 

Viatris continues its efforts to create a portfolio of value-added products, whether in terms of new formulations or delivery innovations, as well as via indication expansion. As far as pain control is concerned, more recently, the introduction of fast-acting meloxicam is part of a sea change in drug development - a drug that is more effective, less toxic, and less addictive and prone to abuse.