MR-107A-02 for Postoperative Pain

No longer recruiting at 14 trial locations

Overseen By Pushpa Baral

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Specialty LLC

Must not be taking: Aspirin, NSAIDs

Disqualifiers: BMI >40, GI bleeding, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well the new drug MR-107A-02 relieves pain after bunion surgery. Researchers will compare MR-107A-02 to tramadol, a common pain medication, and a placebo to assess which is most effective and safe. Individuals who have undergone bunion surgery and experience moderate to severe pain afterward might be suitable for this trial. Participants should be able to understand and complete study requirements, such as filling out diaries and questionnaires. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potential new pain relief option.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a condition that requires pain medication not related to the bunionectomy, you may be excluded from the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MR-107A-02 is generally safe and well-tolerated. In earlier studies, the treatment caused about the same number of side effects as a placebo, which is a harmless pill like a sugar pill. This finding suggests that MR-107A-02 is relatively safe, as participants did not experience more side effects than those taking the placebo. This is a positive sign for its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about MR-107A-02 because it offers a potentially new way to manage postoperative pain. Unlike standard treatments like opioids or NSAIDs, MR-107A-02 is administered as a 15 mg dose twice daily, which could simplify dosing schedules and improve patient compliance. Additionally, MR-107A-02 might provide effective pain relief with fewer side effects compared to traditional options like tramadol, which is often taken every six hours and can have more pronounced side effects. This innovative approach could make postoperative recovery more comfortable and manageable for patients.

What evidence suggests that MR-107A-02 could be an effective treatment for postoperative pain?

Research has shown that MR-107A-02, which participants in this trial may receive, effectively eases pain after bunion surgery. It provides better pain relief than a placebo, helping patients recover more quickly. Patients using MR-107A-02 required fewer opioids, which are strong painkillers with potential side effects. One study found that people experienced faster and more noticeable pain reduction with MR-107A-02. This suggests that MR-107A-02 could be a promising option for managing post-surgery pain effectively and safely. ^{1 4 5 6 7}

Who Is on the Research Team?

Susanne Vogt

Principal Investigator

Viatris Inc.

Are You a Good Fit for This Trial?

This trial is for individuals experiencing acute pain after bunionectomy surgery. Specific eligibility criteria are not provided, but typically participants must be adults who have undergone the procedure and meet certain health standards.

Inclusion Criteria

I experience pain level 4 or higher after a specific nerve block procedure.

I need surgery for a bunion on one foot.

My health is good enough for surgery, according to anesthesia guidelines.

Exclusion Criteria

I have a painful condition not related to my foot surgery that needs pain management.

My body weight is less than 43 kg.

I have an active inflammatory bowel condition like Crohn's or ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-patient Treatment

Participants receive MR-107A-02, tramadol, or placebo for acute postoperative pain management

48 hours

In-patient stay

Out-patient Treatment

Participants continue receiving MR-107A-02 or placebo for pain management at home

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

What Are the Treatments Tested in This Trial?

Interventions

• MR-107A-02
• Placebo
• Tramadol

Trial Overview

The study is testing MR-107A-02's effectiveness and safety in managing post-surgical pain from a bunionectomy compared to Tramadol (a known pain medication) and a placebo (an inactive substance).

How Is the Trial Designed?

Group I: MR-107A-02 Experimental Treatment 2 Interventions

15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .

Group II: Tramadol Active Control 3 Interventions

50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization). Placebo will be administered during out patient phase.

Group III: Placebo Placebo Group 2 Interventions

Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.

Who Is Running the Clinical Trial?

Viatris Specialty LLC

Lead Sponsor

Trials

3

Recruited

170+

Mylan Specialty, LP

Industry Sponsor

Trials

4

Recruited

1,200+

Published Research Related to This Trial

Effective postoperative pain management requires a multimodal approach tailored to the specific type of surgery, which can enhance patient comfort and reduce complications.

Recent advancements in pain management include the rediscovery of existing medications like Gabapentin and new combinations like oral oxycodone with naloxone, highlighting the ongoing evolution of analgesic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New substances and applications for postoperative pain therapy]. Pogatzki-Zahn, EM., Zahn, PK.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06215820

NCT06215820 | Study of MR-107A-02 for the Treatment of ...

Study Overview. MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.

2.

newsroom.viatris.com

newsroom.viatris.com/2025-05-08-Viatris-Announces-Positive-Top-Line-Results-from-Two-Pivotal-Phase-3-Studies-of-Novel-Fast-Acting-Meloxicam-MR-107A-02-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain

Press Releases

MR-107A-02 demonstrated statistically significant and clinically meaningful improvement in pain compared to placebo, significant reduction in opioid usage and ...

3.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/novel-meloxicam-formulation-reduces-postop-pain-in-two-trials/

Novel Meloxicam Formulation Reduces Postop Pain in 2 ...

A significantly shorter time to perceptible and meaningful pain relief was seen in participants receiving MR-107A-02 compared with placebo and a ...

4.

painweek2025.eventscribe.net

painweek2025.eventscribe.net/ajaxcalls/PresentationInfo.asp?efp=UEFTRVdOUE0yNTUzNQ&PresentationID=1668956&rnd=0.9193771

(Poster #76) Time to Efficacy Onset of MR-107A-02 (Novel ...

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 ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/17425247.2025.2561710

Comparison of the pharmacokinetics of MR-107A-02, a ...

1. Acute moderate-to-severe pain in the post-operative setting can significantly affect patient recovery and reduce satisfaction and overall quality of life ...

6.

newsroom.viatris.com

newsroom.viatris.com/2025-08-01-Viatris-Announces-Five-Data-Presentations-on-Novel-Fast-Acting-Meloxicam-MR-107A-02-at-PAINWeek-2025-Conference

Press Releases

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

7.

viatris.gcs-web.com

viatris.gcs-web.com/news-releases/news-release-details/viatris-announces-five-data-presentations-novel-fast-acting

Viatris Announces Five Data Presentations on Novel Fast ...

Viatris Announces Five Data Presentations on Novel Fast-Acting Meloxicam (MR-107A-02) at PAINWeek 2025 Conference ... Postoperative Pain Following. Bunionectomy ...