The FDA has accepted Viatris’ New Drug Application for fast-acting meloxicam (MR-107A-02), an investigational non-opioid therapy for moderate-to-severe acute pain, and assigned a decision date of December 27, 2026.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Viatris has reached a key milestone with the FDA’s acceptance of its New Drug Application (NDA) for a fast-acting formulation of meloxicam (MR-107A-02), designed to treat moderate-to-severe acute pain. The FDA has set a decision date of December 27, 2026.
If approved, this non-opioid option could provide safer relief for the more than 80 million Americans who experience acute pain each year, helping to reduce reliance on opioids.
Philippe Martin, Chief R&D Officer at Viatris, stated: “We’re one step closer to giving patients a powerful, non-opioid option for severe pain.” He emphasized the treatment’s rapid onset and sustained relief, which together significantly reduce the need for opioid rescue medication. Supported by robust clinical data and a well-established safety profile, the therapy addresses a pressing public health need.
The NDA is backed by results from two Phase 3 trials presented at PAINWeek 2025:
- Herniorrhaphy trial (NCT06215859): 579 patients randomized to fast-acting meloxicam, tramadol, or placebo.
- Bunionectomy trial (NCT06215820): 410 patients randomized similarly.
Both studies followed patients through an inpatient phase (0–48 hours post-surgery) and an outpatient phase. In both settings, fast-acting meloxicam met all primary and secondary endpoints, delivering significant pain relief, reducing opioid rescue doses, and lowering the proportion of patients requiring opioids. Safety outcomes were consistent with the known NSAID profile.
Acute pain, often triggered by surgery or injury, disrupts recovery and sleep, and drives opioid prescribing. More than half of surgical patients report inadequate pain control, underscoring the urgent need for effective non-opioid alternatives.
Fast-acting meloxicam is engineered to dissolve and absorb more quickly than conventional formulations, offering rapid relief while maintaining long-lasting efficacy. While meloxicam is already widely used as an NSAID, this novel version represents a meaningful advance in acute pain management. It remains investigational and is currently under FDA review.
Viatris’ broader strategy focuses on enhancing proven medicines through innovations such as faster delivery systems, new formulations, and expanded indications. By modernizing established therapies, the company aims to deliver high-value medicines that improve patient outcomes and maximize product potential.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.