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

P-038 - (Poster #38) Efficacy and safety of MR-107A-02 (novel meloxicam fast-acting formulation) for the treatment of acute moderate-to-severe pain following herniorrhaphy

Thursday, September 4, 2025
4:00 PM - 5:30 PM PST
Location:  Exhibit Hall (Level 4)

    Author/Presenter(s)

  • Todd Bertoch, MD

    Chief Medical Office, Principal Investigator
    CenExel Clinical Research
    Salt lake, Utah

  • HM

    Harold Minkowitz, MD

    President – Analgesics, Perioperative & Hospital Based Research
    Evolution Research Group
    New Providence, New Jersey

  • SV

    Susanne R. Vogt, n/a

    Senior Clinical Sciences Lead
    Viatris
    Bad Homburg vor der Höhe, Hessen

  • SH

    Scott Haughie, MS

    Statistics Team Lead
    Viatris/Mylan Pharma UK Ltd.
    Sandwich, England

  • KO

    Kathleen Ocasio, BS

    Senior Director, Global Clinical Operations
    Viatris
    Canonsburg, Pennsylvania

  • JS

    Jeffrey Smith, Ph.D.

    Head of Preclinical and Toxicology
    Viatris
    Morgantown, West Virginia

Background: Managing acute pain is crucial. Although opioids are effectively used in acute moderate-to-severe pain management, they are associated with unwanted tolerance, dependence, overdose and death. Of the total 107,543 drug overdose deaths in the US in 2023, 75% involved opioid overdose. There is an unmet need for analgesics that can treat acute severe pain and serve as a treatment alternative to opioids, reducing the risk of opioid-related adverse effects. Meloxicam is a member of the non-steroidal anti-inflammatory drug (NSAID) group of medications that have been shown to exhibit anti-inflammatory and analgesic activity. However, currently approved oral formulations of meloxicam that are indicated for the treatment of chronic pain are not suitable for the treatment of acute pain due to their slow absorption and delayed onset of effects.

Purpose/Objectives: MR-107A-02 is a novel formulation of meloxicam currently in development by Viatris. This fast-acting formulation offers rapid absorption and can be effectively used to treat moderate-to-severe acute pain. Herniorrhaphy, a soft tissue surgery model, has adequate sensitivity and has been used in evaluating the efficacy of analgesics in the management of acute moderate-to-severe pain. This phase III study was designed to assess the safety and efficacy of MR-107A-02 in the reduction of acute pain in patients after herniorrhaphy.

Methods: This multi-center, randomized, double-blind, placebo (double-dummy) and active-controlled, parallel group study was conducted at 17 centers in the United States. Patients experiencing the requisite level of pain (score ≥4 on an 11-point numeric rating scale-activity [NRS-A] from 0 = no pain to 10 = worst possible pain) after herniorrhaphy were randomized to receive MR-107A-02 15 mg (BID), placebo or tramadol 50 mg (QID) in 2:2:1 ratio. The primary endpoint was the summed pain intensity difference over 0-48 hours (SPID0-48) based on NRS-A for MR-107A-02 versus placebo. The times to perceptible and meaningful pain relief were measured using the double-stopwatch technique after the first dose to quantify the onset of pain relief. The study was approved by Institutional Review Board (IRB) and informed consent was obtained from all study participants.

Results:

Of 579 randomized participants (232 MR-107A-02, 231 placebo,116 tramadol; 96.3% males;84 % whites; mean [SD] age, 49.1 [12.21] years; weight range, 44-152 kg), 551 participants completed the study. The baseline NRS-A scores (mean [SD]) were similar across all three groups (7.8 [1.66] MR-107A-02, 7.7 (1.68) placebo, 7.8 [1.57] tramadol).

The primary endpoint SPID0-48 (NRS-A), for MR-107A-02 versus placebo, was met. The least squares mean (SE) [95% CI] of SPID0-48 (NRS-A) for MR-107A-02 was 163.1 (8.99) [145.5, 180.7] vs. 113.0 (9.16) [95.0, 131.0] for placebo, with treatment difference of 50.1 (7.48) [35.4, 64.8], p < 0.001. Assay sensitivity was demonstrated with tramadol versus placebo, showing a treatment difference of 29.5 (9.0) [14.7, 44.3]; p < 0.001.

In post-hoc analysis, MR-107A-02 showed a higher SPID0-48 compared to tramadol: 162.2 (11.05) [140.5, 183.8] vs. 141.3 (12.16) [121.3, 161.2], with a treatment difference of 20.9 (9.34) [5.6, 36.3], p = 0.025.

MR-107A-02 demonstrated a shorter time to perceptible pain relief compared to placebo (median [CI], hours) (0.9 [0.8, 1.0] vs 1.1 [0.9, 2.1]; p= 0.014) and was comparable to tramadol (0.9 [0.7, 1.5]).

Time to meaningful pain relief was also shorter for MR-107A-02 compared to placebo (median [CI], hours) (3.7 [2.9, 5.3] vs NA [4.1, NA]; p= 0.025) and tramadol (5.0 [3.0, NA]). Both the 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 during the in-patient phase. The number of severe or serious TEAEs was lower in MR-107A-02  and comparable to placebo. During the in-patient treatment period, the most common adverse events (AEs) in the MR-107A-02 group were constipation (7.0%, MR-107A-02; 14.1%, placebo; 20.9%, tramadol), dizziness (5.7%,5.3%,11.3%), headache (5.2%, 7.9%, 4.3%), and hyperhidrosis (6.5%, 6.6%, 7.0%).

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

MR-107A-02 (15 mg BID) was effective in reducing the acute, moderate-to-severe pain following herniorrhaphy, as demonstrated by SPID0-48 values compared with placebo, and with a superior efficacy profile to its opioid comparator. The twice daily dose of MR-107A-02 produced a rapid onset of analgesia, as evidenced by the shorter time taken to achieve meaningful pain relief compared to placebo, with a well-tolerated safety profile.