MR-107A-02 in Acute Postoperative Pain Management Following Bunionectomy: Results from a Multicenter, Placebo- and Active-Controlled, Phase 3 Trial

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Introduction MR-107A-02 is a novel, fast-absorbing oral meloxicam formulation designed to deliver effective analgesia in moderate-to-severe acute pain settings. Methods This phase 3, randomized, double-blind, placebo- and active-controlled, parallel-group study assessed the efficacy and safety of MR-107A-02 in participants following bunionectomy. Participants with a postoperative pain numerical rating scale at rest (NRS-R) score ≥ 4 and a moderate or severe qualifying categorical pain score were randomized in a 1:1:1 ratio to receive MR-107A-02 15 mg (BID), placebo, or tramadol 50 mg (q6h). The primary endpoint was the summed pain intensity difference over 48 h (SPID0–48) for MR-107A-02 versus placebo, based on NRS-R. Tramadol was included as an active control for assay sensitivity and comparisons between MR-107A-02 and tramadol were exploratory. Key secondary endpoints included the use of opioid rescue medication, proportion of opioid-free participants and time to perceptible and meaningful pain relief. Results Of the 410 randomized participants, 397 completed the study. Baseline NRS-R scores were similar across groups. MR-107A-02 met the primary endpoint, with a significantly greater SPID0-48 than placebo (183.9 vs. 101.2; difference, 82.7; p < 0.001). Assay sensitivity was confirmed with tramadol versus placebo (difference, 58.0; p < 0.001). In an exploratory, post hoc analysis that was not powered for hypothesis testing in this protocol, the estimated SPID0–48 was numerically higher with MR-107A-02 in comparison to tramadol (174.3 vs. 148.1; difference, 26.2; nominal p = 0.013). MR-107A-02 reduced opioid rescue use by 59% versus placebo (p < 0.001), with more participants remaining opioid-free in the MR-107A-02 group than in the placebo (56.9% vs. 33.1%; difference 23.8%; p < 0.001). The median time to perceptible (0.7 h vs. 0.9 h, p = 0.037) and meaningful pain relief (2.4 h vs. 5.1 h, p = 0.012) were earlier in the MR-107A-02 than the placebo. MR-107A-02 was well-tolerated. In the MR-107A-02 group, all treatment emergent adverse events (TEAEs) were mild or moderate in severity, and no severe TEAEs, serious adverse events, or study discontinuations due to TEAEs were reported. The incidence of opioid-related adverse events in the MR-107A-02 group was 16.1%, which was lower than that observed with tramadol (46.0%), and was comparable to placebo (16.9%) during the first 48 h of treatment. Conclusions MR-107A-02 provided statistically significant analgesic efficacy, faster onset of action, good tolerability, and reduced opioid rescue medication compared with placebo, highlighting its opioid-sparing potential. These findings should be interpreted within the constraints of the bunionectomy model, and confirmation in broader surgical settings is warranted. Clinical Trial Registration ClinicalTrials.gov identifier: NCT06215820.

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