Fast-Acting Meloxicam Demonstrates Postoperative Pain Relief and Opioid-Sparing Potential

An investigational fast-acting oral formulation of meloxicam, MR-107A-02 (Viatris), demonstrated significant analgesic efficacy with a faster onset of relief and lower rescue opioid use following bunionectomy, according to results from a phase 3 trial published in Pain and Therapy.¹ The findings add to a clinical program supporting the formulation’s use for moderate to severe acute pain while its new drug application (NDA) undergoes FDA review.

MR-107A-02 was developed to overcome the delayed absorption of conventional oral meloxicam. Although meloxicam has an established role as a nonsteroidal anti-inflammatory drug (NSAID), standard formulations may not reach therapeutic concentrations quickly enough for some acute-pain settings. MR-107A-02 is designed to dissolve and absorb more rapidly while maintaining overall drug exposure comparable to reference meloxicam.²

Phase 3 Trial Evaluates Bunionectomy Pain

The multicenter, randomized, double-blind phase 3 trial (NCT06215859) enrolled 410 adults experiencing moderate to severe postoperative pain after bunionectomy, a standardized model of acute bony pain. Participants were randomly assigned 1:1:1 to receive MR-107A-02 at 15 mg twice daily, placebo, or tramadol at 50 mg every 6 hours. Tramadol served as an active comparator to establish the sensitivity of the study model.¹

The primary end point was the summed pain intensity difference at rest from baseline through 48 hours, known as SPID_0-48. Investigators also evaluated the onset of pain relief, rescue medication requirements and safety.

MR-107A-02 significantly improved SPID_0-48 compared with placebo. The least-squares mean treatment difference was 82.7 points (95% CI, 62.0-103.4; P < .001).^1,3 A post-hoc comparison also indicated greater pain control with MR-107A-02 than with tramadol, although the trial was not primarily designed to establish superiority over the opioid comparator.³

The median time to perceptible pain relief was about 0.9 hours with MR-107A-02 compared with 1.1 hours with placebo. Meaningful relief occurred at a median of 3.7 hours with MR-107A-02, whereas the median could not be estimated for placebo during the assessment period.¹

Rescue Opioid Use Declines

The findings also demonstrated an opioid-sparing effect. Across the inpatient and outpatient treatment periods, approximately 56.9% of participants who were assigned to MR-107A-02 remained opioid free compared with 33.1% receiving placebo (P < .001).³ Participants in the investigational-treatment group also required fewer doses of opioid rescue medication.

Similar results were reported in a separate phase 3 trial involving 579 participants following herniorrhaphy, which served as an acute soft-tissue pain model. In that study, MR-107A-02 produced a 50.1-point improvement in SPID₀–₄₈ compared with placebo (95% CI, 35.4-64.8; P < .001). Approximately 72.6% of patients receiving MR-107A-02 remained opioid free, whereas 58.6% in the placebo group did (P = .002).³˒⁴

Together, the studies demonstrate efficacy across 2 distinct postoperative settings. However, controlled surgical models may not represent the broader population encountered in community practice, including patients with multiple comorbidities, complex medication regimens or acute nonsurgical pain.

Safety and Regulatory Review

MR-107A-02 was generally well tolerated in the bunionectomy trial. Frequently reported adverse events (AEs) included constipation, dizziness, headache and hyperhidrosis. The incidence of treatment-emergent AEs was comparable to placebo, and there were no treatment-related deaths reported across the phase 3 program.¹˒³

If approved, the formulation would retain the clinical considerations associated with NSAID therapy. Pharmacists would need to assess cardiovascular, gastrointestinal, and renal risks while identifying concurrent anticoagulants, antiplatelet therapies, or other NSAIDs that might increase toxicity. The lowest effective dose for the shortest necessary duration remains an important principle when NSAIDs are used for acute pain.

The FDA accepted the NDA for MR-107A-02 in May 2026 and assigned a Prescription Drug User Fee Act goal date of December 27, 2026.⁵ The agency’s acceptance confirms that the application is sufficiently complete for review; however, it does not mean that approval is assured.

For pharmacists, the phase 3 findings suggest that faster drug absorption could expand the utility of an established NSAID mechanism in acute pain. Comparative effectiveness, labeling, and patient-selection criteria will ultimately determine whether MR-107A-02 can reduce opioid exposure without compromising postoperative pain control.

REFERENCES

1. Bertoch T, McCoun JC, Gottlieb I, et al. MR-107A-02 in Acute Postoperative Pain Management Following Bunionectomy: Results from a Multicenter, Placebo- and Active-Controlled, Phase 3 Trial. Pain Ther. Published online July 27, 2026. doi:10.1007/s40122-026-00870-7

2. Hummel MA, Shaw A, Liu MS, Jaiswal A, Smith JP, Bertoch T. Comparison of the pharmacokinetics of MR-107A-02, a novel fast-absorbing formulation of meloxicam, versus standard meloxicam reference: a phase I study. Expert Opin Drug Deliv. 2025;22(12):1977-1984. doi:10.1080/17425247.2025.2561710

3. Viatris announces positive top-line results from two pivotal phase 3 studies of novel fast-acting meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain. Viatris. News release. May 8, 2025. Accessed September 1, 2026. https://newsroom.viatris.com/2025-05-08-Viatris-Announces-Positive-Top-Line-Results-from-Two-Pivotal-Phase-3-Studies-of-Novel-Fast-Acting-Meloxicam-MR-107A-02-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain

4. ClinicalTrials.gov. Study of MR-107A-02 for the treatment of acute postoperative pain following herniorrhaphy. ClinicalTrials.gov identifier: NCT06215859. Updated April 15, 2025. Accessed September 1, 2026. https://clinicaltrials.gov/study/NCT06215859

5. US FDA accepts Viatris new drug application for fast-acting meloxicam for the treatment of moderate-to-severe acute pain. Viatris. News release. May 18, 2026. Accessed September 1, 2026. https://investor.viatris.com/news-releases/news-release-details/us-fda-accepts-viatris-new-drug-application-fast-acting