MR-107A-02 for Postoperative Pain

No longer recruiting at 18 trial locations

Overseen By Diane Musselwhite

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Specialty LLC

Must not be taking: Aspirin, NSAIDs

Disqualifiers: Obesity, Low weight, 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 tests a new treatment called MR-107A-02, a potential new drug, to evaluate its effectiveness and safety in easing pain after hernia surgery. Participants will be divided into groups to receive either MR-107A-02, tramadol, or a placebo (a non-active substance). The goal is to determine which treatment best reduces post-surgery pain. Individuals requiring hernia surgery and experiencing moderate to severe pain afterward might be suitable for this trial. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking pain relief treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

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

Research has shown that MR-107A-02 is generally well-tolerated for treating acute pain. In studies involving surgical patients, the number of unwanted side effects was similar to those who received a placebo, a non-active treatment. This suggests that MR-107A-02 does not cause more side effects than a placebo.

However, the available safety information remains somewhat limited. More research with diverse populations is needed to fully understand its safety profile. So far, MR-107A-02 appears to be as safe as other treatments. ^{1 2 3 4 5}

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

MR-107A-02 is unique because it offers a potentially more effective and consistent option for managing postoperative pain. Unlike traditional pain relievers like opioids, which can have significant side effects and risk of dependency, MR-107A-02 is designed to be taken twice daily, providing a steady pain relief without the peaks and troughs often associated with other medications. Additionally, MR-107A-02 may have a different mechanism of action, which could offer pain relief with fewer side effects. Researchers are excited about this treatment because it could offer a safer, more reliable way to manage pain after surgery.

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

Research has shown that MR-107A-02, which participants in this trial may receive, effectively reduces sudden pain. In studies, MR-107A-02 relieved pain more effectively than a placebo, a pill with no active medicine. Patients experienced faster relief, feeling better sooner. This treatment also decreased the need for opioids, strong painkillers with potential side effects. These findings suggest that MR-107A-02 might be a useful option for managing pain after surgery. ^{1 3 4 5 6}

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 undergoing herniorrhaphy, which is surgery for a hernia repair. Specific eligibility criteria are not provided, but typically participants must be adults who have just had this surgery and meet certain health standards.

Inclusion Criteria

Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

My health is good enough for surgery according to the ASA scale.

I experienced moderate to severe pain after surgery.

Exclusion Criteria

Body mass index (BMI) >40 kg/m2 at screening.

I have been treated with MR 107A 02 before.

I have had surgery for an inguinal hernia in the last 2 years.

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, placebo, or tramadol for acute postoperative pain management

48 hours

In-patient stay

Out-patient Treatment

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

5 days

Daily self-administration

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

Trial Overview

The study is testing the effectiveness and safety of a medication called MR-107A-02 in managing post-surgery pain. It's being compared to Tramadol, a known pain reliever, and a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: MR-107A-02 Experimental Treatment 1 Intervention

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 2 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 1 Intervention

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]

A multicomponent intervention that included a clinical pain pathway and education for nurses significantly improved pain management in postoperative patients, particularly those with opioid tolerance, leading to faster pain relief and higher patient satisfaction.

Post-intervention, the time to achieve adequate pain relief for opioid-tolerant patients decreased from 32.7% requiring over 60 minutes to just 21.3%, and the average PACU discharge time improved by 53 minutes, indicating enhanced recovery quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Improve Postoperative Pain with a Clinical Pathway and Nursing Education Program. Naqib, D., Purvin, M., Prasad, R., et al.[2019]

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 ...

The potential for fast pain relief from an orally administered meloxicam product may improve patient comfort, support better adherence to the treatment, and ...

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.