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Efficacy and safety of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy

P-039 - (Poster #39) Efficacy and safety of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy

Thursday, September 4, 2025
4:00 PM - 5:30 PM PST
Location:  Exhibit Hall (Level 4)
Background: Effective treatment of acute moderate-to-severe pain is critically important. Historically, opioid analgesics have been one of the primary treatment choices for many types of acute pain due to a lack of suitable non-opioid alternatives. Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), has demonstrated both anti-inflammatory and analgesic activity. However, its currently approved oral formulations are indicated for chronic pain management only and are unsuitable for acute pain due to their slow absorption and delayed onset of action.

Purpose/Objectives: MR-107A-02, a novel fast-acting meloxicam formulation developed by Viatris, is designed for rapid absorption to deliver effective analgesia in moderate-to-severe acute pain settings. The bunionectomy model is a well-accepted and established model that primarily involves hard tissue (bone) pain and is considered by regulatory agencies as representative of acute pain states in general. It provides sufficient sensitivity to assess analgesic efficacy and supports the evaluation of the opioid-sparing potential of non-opioid analgesics. This phase III study was designed to assess the safety and efficacy of MR-107A-02 in reducing acute pain in patients following bunionectomy.

Methods:

This multi-center, randomized, double-blind, placebo (double-dummy) and active-controlled, parallel group study was conducted at 14 centers in the United States. Patients experiencing the requisite level of pain (score ≥4 on an 11-point numeric rating scale-rest [NRS-R] from 0 = no pain to 10 = worst possible pain) after bunionectomy were randomized in a 1:1:1 ratio to receive MR-107A-02 15 mg (BID), placebo, or tramadol 50 mg (QID). The primary endpoint was the summed pain intensity difference over 0-48 hours (SPID0-48) based on NRS-R for MR-107A-02 versus placebo. To quantify the onset of pain relief, times to perceptible and meaningful pain relief were measured using the double-stopwatch technique after the first dose. The study was approved by Institutional Review Board (IRB) and informed consent was obtained from all participants.

Results:

Of the 410 randomized participants (137 MR-107A-02, 136 placebo,137 tramadol; 85.9% females; 60% whites; mean [SD] age, 48 [13.4] years; weight range, 45-126 kg), 397 participants completed the study. Baseline NRS-R scores (mean [SD]) were similar across all the three groups (7.2 [1.67] MR-107A-02, 7.6 [1.73] placebo and 7.2 [1.64] tramadol).

The primary endpoint SPID0-48 (NRS-R), comparing MR-107A-02 to placebo, was met. The least squares mean (SE) [95% CI] of SPID0-48 (NRS-R) for MR-107A-02 was 183.9 (10.64) [163.0, 204.7] vs. 101.2 (10.83) [80.0, 122.4] for placebo with a treatment difference of 82.7 (10.54) [62.0, 103.4]; p < 0.001. Assay sensitivity was demonstrated with tramadol versus placebo, showing a treatment difference of 58.0 (10.39) [40.9, 75.1]; p < 0.001.

In a post-hoc analysis, MR-107A-02 showed a higher SPID0-48 compared to tramadol: 174.3 (10.45) [153.8, 194.7] vs. 148.1 (10.66) [130.5, 165.6], with a treatment difference of 26.2 (10.58) [8.8, 43.6]; p = 0.013.

MR-107A-02 had a shorter time to perceptible pain relief compared to placebo (median [CI], hours) (0.7 [0.6, 0.9] vs 0.9 [0.6, 5.8]; p = 0.037) and tramadol (0.8 [0.6, 0.9]).

Time to meaningful pain relief was also shorter for MR-107A-02 compared to placebo (median [CI], hours) (2.4 [1.9, 3.0] vs 5.1 [3.1, NA]; p = 0.012) and tramadol (3.4 [2.6, 4.9]). Both pain relief endpoints demonstrated a significantly faster onset of action for MR-107A-02 compared to placebo.
Overall, MR-107A-02 was well-tolerated with the fewest treatment emergent adverse events (TEAEs) among all groups. There were no severe or serious TEAEs reported in the MR-107A-02 group. During the in-patient treatment period, the most common adverse events (AEs) in the MR-107A-02 group were nausea (5.8%, MR-107A-02;10.3%, placebo; 38.0%, tramadol), dizziness (2.9%, 6.6%,18.2%), headache (6.6%, 4.4%, 6.6%) and pruritus (5.1%, 2.9%, 8.8%).

Conclusions/Implications for future research and/or clinical care:

MR-107A-02 (15 mg BID) demonstrated statistically significant reduction in acute, moderate-to-severe pain following bunionectomy, as evidenced by SPID 0-48 values compared to placebo, and showed a superior profile relative to its opioid comparator. MR107A-02 also demonstrated fast onset of action and a favorable safety profile.