Non-Opioid Drug Significantly Reduced Pain After Surgery, Studies Reveal

Treatment with MR-107A-02 (meloxicam; Viatris, Pittsburgh, PA), a novel, oral, fast-acting formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, was shown to significantly reduce pain and opioid usage vs placebo in top-line results from 2 phase 3 clinical studies. Additionally, in post-hoc analyses, MR-107A-02 was shown to be superior to treatment with the opioid tramadol for pain control.

These topline results were reported from 2 phase 3 studies investigating the safety and efficacy of MR-107A-02 vs placebo and the opioid agonist tramadol for treating post-operative moderate-to-severe pain following herniorrhaphy (NCT06215859) and bunionectomy (NCT06215820). A total of 828 participants across the 2 studies—579 who underwent herniorrhaphy and 410 who underwent bunionectomy—were randomized to receive treatment with MR-107A-02 15 mg, tramadol 50 mg, or placebo

In both studies, the primary end point of summed pain intensity difference (SPID) from 0 to 48 hours  after randomization for MR-107A-02 vs placebo was met.

Key Herniorrhaphy Study Results:

• After herniorrhaphy, the least squares (LS) mean difference in SPID was 50.1 for MR-107A-02 vs placebo (95% CI, 35.4 to 64.8; P<.001).
• 72.6% of participants who received MR-107A-02 in the herniorrhaphy study were opioid-free 7 days after randomization compared with 58.6% in the placebo arm (P=.002).

Key Bunionectomy Study Results:

• After bunionectomy, the LS mean difference in SPID was 82.7 for MR-107A-02 vs placebo (95% CI, 62.0 to 103.4; P<.001).
• 56.9% of participants who received MR-107A-02 in the bunionectomy study were opioid-free 7 days after randomization compared with 33.1% in the placebo arm (P<.001).

In both studies, according to a statement from Viatris, MR-107A-02 was generally well tolerated and comparable to placebo in terms of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). Additionally, the company states that findings from post-hoc analyses demonstrate that treatment with MR-107A-02 was superior to tramadol in terms of pain control (SPID). MR-107A-02 further demonstrated a shorter time to perceptible and meaningful pain relief vs placebo and a shorter or comparable time to perceptible and meaningful pain relief vs tramadol in results from post-hoc analyses.

The company plans to submit a New Drug Application to the Food and Drug Administration (FDA) by the end of the year.