A randomized, double-blind, placebo-controlled, parallel group, dose-response study of MR-107A-02 in the treatment of post-surgical dental pain
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 < .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.
Clinicaltrial.gov identifier: NCT05317312 https://clinicaltrials.gov/study/NCT05317312
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BibTeX
@article{bertoch2026randomized,
title = {{A randomized, double-blind, placebo-controlled, parallel group, dose-response study of MR-107A-02 in the treatment of post-surgical dental pain}},
author = {Todd Mitchell Bertoch and Seth Grisham and Susanne Vogt and Scott Haughie and Kathleen Ocasio and Jeffrey P Smith},
journal = {Pain Medicine: The Official Journal of the American Academy of Pain Medicine},
year = {2026},
month = jul,
doi = {10.1093/pm/pnag095},
url = {https://doi.org/10.1093/pm/pnag095},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - A randomized, double-blind, placebo-controlled, parallel group, dose-response study of MR-107A-02 in the treatment of post-surgical dental pain
AU - Todd Mitchell Bertoch
AU - Seth Grisham
AU - Susanne Vogt
AU - Scott Haughie
AU - Kathleen Ocasio
AU - Jeffrey P Smith
PY - 2026
DA - 2026/07/26
JO - Pain Medicine: The Official Journal of the American Academy of Pain Medicine
DO - 10.1093/pm/pnag095
UR - https://doi.org/10.1093/pm/pnag095
AB - 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 < .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. Clinicaltrial.gov identifier: NCT05317312 https://clinicaltrials.gov/study/NCT05317312
SN - 1526-2375
SN - 1526-4637
ER -