P-076 - (Poster #76) Time to Efficacy Onset of MR-107A-02 (Novel Fast-Acting Meloxicam Formulation) in the Treatment of Acute Postoperative Pain Following Bunionectomy and Herniorrhaphy

Background: Meloxicam is a member of the non-steroidal anti-inflammatory drugs (NSAIDs) group of medications, shown to exhibit anti‑inflammatory and analgesic activity in clinical studies. NSAIDs have demonstrated efficacy in the treatment of acute pain as well as in chronic pain. The study drug (MR‑107A‑02), a rapid absorbing form of meloxicam, has been developed to provide rapid absorption of meloxicam through administration and has been studied in two Phase 1 studies (MELO‑TFZ‑1001 and MR‑107A‑TFZ‑1001) in healthy subjects.

Efficacy and safety of this oral formulation has been explored in a Phase 2b study (MELO‑TFZ-2001) in healthy subjects with acute pain after dental surgery. Meloxicam 5 mg and 15 mg dose groups met the primary efficacy endpoint, with statistically significant differences from placebo in the maximum effect (Emax) estimates for summed pain intensity difference over 0-24 hours (SPID0-24h) (p < 0.001 for both doses). 

MR‑107A‑02 has been further studied in two Phase 3 trials in treating postoperative pain, in both a bony pain model (bunionectomy) and a soft tissue pain model (herniorrhaphy). The primary endpoint using the SPID0-48h, was achieved (p < 0.001 for both studies). In both studies, meloxicam demonstrated statistically significant and clinically meaningful results across the primary and secondary endpoints.

Purpose/Objectives: Effective post-surgical pain management is critical to optimizing functional recovery and minimizing the risk of complications and long-term pain outcomes. Despite well-documented adverse effects and the potential for misuse, abuse, and diversion, opioids remain a central component of post-operative analgesia. The opioid crisis has spurred increased interest in evaluating the effectiveness of non-opioid treatments for both acute and chronic pain.
The analyses presented in this poster with provide further evidence of the safety and efficacy profile of MR‑107A‑02 as an alternative non-opioid pain management tool.

Methods:

Two independent Phase 3 multi-center, randomized, double-blind, placebo- (double-dummy) and active-controlled, parallel-group studies were completed for the treatment of acute postoperative pain, in bunionectomy (MR-107A-02-TFZ-3001) and herniorrhaphy (MR-107A-02-TFZ-3002). The investigational drug MR‑107A‑02 15mg BID was tested alongside the active comparator of Tramadol 50mg q6H, and the dummy arm of Placebo.

For MR-107A-02-TFZ-3001, subjects had bunionectomy performed under IV sedation, a regional popliteal block and a local Mayo block. For MR-107A-02-TFZ-3002, subjects had inguinal herniorrhaphy performed under general anaesthesia. For both studies, subjects with an eligibility pain assessment of NRS‑R  (Numeric Rating Scale at Rest) ≥4 and a rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) were eligible for randomization.

For bunionectomy the primary efficacy endpoint was the summed pain intensity difference over 0-48 hours (SPID_0-48h), using NRS-R. For herniorrhaphy the primary efficacy endpoint was the SPID_0-48h, using NRS-A (Numeric Rating Scale with Activity). Larger values in the SPID_0-48h indicate greater pain reduction. A windowed-last observation carried forward (WLOCF) approach following any rescue medication use was applied, where the pain score just prior to rescue was used to censor any pain scores falling within a pre-determined window following that rescue use.

Results:

This poster will present additional post-hoc analyses that further confirm the superior pain control provided by MR‑107A‑02 in both surgical models, including an analysis of the time to 2-point reduction in the NRS. In bunionectomy, MR-107A-02 demonstrated a statistically significant difference in the time to 2-point reduction in the NRS-R when compared to placebo, along with a shorter median time to 2-point reduction in the NRS-R, in comparison to Tramadol. Similar results were seen for herniorrhaphy, where the difference in the time to 2-point reduction in the NRS-A versus placebo was highly statistically significant.

Additional methodological exploratory analyses may be presented.

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

In both surgical models, these findings, supported by MR-107A-02’s established mechanism of action and well-characterized safety profile, highlight its potential as a first-line treatment option for moderate-to-severe acute pain. The efficacy and benefit-risk profile observed in these pivotal studies underscore the promise of this fast-acting meloxicam formulation as a non-opioid analgesic option for patients with moderate-to-severe acute pain, possibly eliminating opioid use altogether for many patients. 

The Company is targeting to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of 2025 based on the positive data from the two Phase 3 studies and the supportive positive Phase 2 dose range finding study in dental pain.

Studies described in this abstract:

MR-107A-02-TFZ-3001 NCT06215820

MR‑107A‑02‑TFZ‑3002 NCT06215859

Prior supporting studies referenced in this abstract:

MELO-TFZ-2001 NCT05317312