A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-02 in the Treatment of Post-Surgical Dental Pain
In brief
15 mg MR-107A-02 BID halves rescue meds and eases dental pain
In a phase 2b trial of 110 patients after third-molar extraction, the 15 mg twice-daily dose of the new oral meloxicam formulation produced a SPID0-24 score of 94.8 versus 52 for placebo and achieved perceptible relief in about 0.6 hours and meaningful relief in 1.5 hours. It also reduced rescue medication use to roughly 30%, with no serious adverse events, suggesting rapid, dose-dependent analgesia but pending larger confirmatory studies.
- Journal
- Pain medicine (Malden, Mass.) (Q1)
- Published
- 25 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Todd Mitchell Bertoch, Seth Grisham, Susanne Vogt, Scott Haughie, Kathleen Ocasio, Jeffrey P Smith
- PMID
- 42502959
- DOI
- 10.1093/pm/pnag095
Why clinicians should know about it
- Picked for Anesthesiology and Pain Medicine (paper of the day, 27 July 2026).
- Picked for Neurology (clinical) (paper of the day, 27 July 2026).
- Picked for Pharmacology (medical) (paper of the day, 27 July 2026).
- Picked for Surgery (paper of the day, 27 July 2026): High-quality evidence in a top journal
Abstract
BACKGROUND: MR-107A-02 is a novel, oral meloxicam formulation designed to enhance dissolution and absorption for rapid analgesia in acute pain. It demonstrates a favorable pharmacokinetic profile, with a higher Cmax and shorter Tmax than Mobic® (meloxicam tablets), while maintaining similar overall extent of exposure. METHODS: This phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study assessed the efficacy and safety of MR-107A-02 at doses of 1.25, 5, and 15 mg twice daily (BID) following third molar extraction. The primary endpoint was SPID0-24, analyzed in the mITT population using W6LOCF to account for rescue medication use. Pain intensity and categorical ratings were evaluated using standardized pain scales. Onset of perceptible and meaningful pain relief were measured using the double-stopwatch technique. Effect sizes and associated standard errors, p-values, and 95% CIs were estimated using an Emax model. RESULTS: Among 110 participants, MR-107A-02 demonstrated positive dose-dependent analgesia, with mean SPID0-24 Emax values of 70.7 (1.25 mg), 86.7 (5 mg), and 94.8 (15 mg), versus 52.0 for placebo. Significant improvement in SPID0-24 occurred at 5 mg and 15 mg versus placebo (p < 0.001). The 15 mg dose achieved perceptible and meaningful pain relief within 0.6 and 1.5 hours, respectively, and had the lowest rescue medication use (29.6%) compared to 42.9%, 57.1%, and 74.1% in the 1.25 mg, 5 mg, and placebo. No severe TEAEs, SAEs, or discontinuations were reported. CONCLUSIONS: MR-107A-02 was generally well tolerated and demonstrated dose-dependent efficacy, with the 15 mg BID dose providing rapid analgesia and a reduction in rescue medication use.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.