Viatris Inc. (NASDAQ: VTRS) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MR-107A-02, a fast-acting meloxicam intended for the treatment of moderate-to-severe acute pain.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of December 27, 2026 for the review.
The NDA submission is backed by data from a Phase 3 program, which was presented at PAINWeek 2025.
This program included two randomized, double-blind, placebo- and active-controlled trials, conducted after herniorrhaphy and bunionectomy surgeries.
The trials assessed the efficacy and safety of fast-acting meloxicam compared to placebo, with an opioid arm using tramadol to validate the pain model’s sensitivity.
Acute pain impacts over 80 million people annually in the United States, where opioids are frequently used for treatment.
Viatris aims to provide a non-opioid alternative to address this significant public health issue.
Philippe Martin, Viatris Chief R&D Officer, stated, “FDA’s acceptance of the New Drug Application for investigational fast-acting meloxicam takes us one step closer to bringing a potential non-opioid first-line treatment option to patients with moderate-to-severe acute pain, which will help address an important public health need in the United States.”
 announced FDA acceptance of its NDA for fast-acting meloxicam, a non-opioid treatment for acute pain, with a review target date of December 27, 2026.){kind=link}