PITTSBURGH - Viatris Inc. (NASDAQ:VTRS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for MR-107A-02, a fast-acting formulation of meloxicam intended to treat moderate-to-severe acute pain.
The FDA assigned a Prescription Drug User Fee Act goal date of Dec. 27, 2026. The drug is a non-opioid treatment option for acute pain, which affects over 80 million individuals in the United States each year.
The application is supported by data from two Phase 3 randomized, double-blind trials evaluating the drug after herniorrhaphy and bunionectomy surgeries. The trials included 579 herniorrhaphy patients and 410 bunionectomy patients aged 18 or older.
Both studies compared fast-acting meloxicam against placebo and included a tramadol arm to confirm pain model sensitivity. The primary endpoint measured Sum of Pain Intensity Difference over 0-48 hours versus placebo.
According to the company, both studies met primary and secondary endpoints and demonstrated a safety profile consistent with the mechanism of action.
"FDA's acceptance of the NDA for investigational fast-acting meloxicam brings us closer to offering a potential non-opioid first-line treatment for patients with moderate-to-severe acute pain," said Philippe Martin, Viatris Chief R&D Officer.
