What side effects are associated with this type of intervention?

Common treatments for acute pain, such as NSAIDs (e.g., ibuprofen, naproxen) and other analgesics, often come with side effects. NSAIDs can cause gastrointestinal issues like ulcers and bleeding, renal impairment, and cardiovascular risks. Analgesics like acetaminophen are generally safer for the stomach but can lead to liver toxicity, especially at high doses. Opioids, another class of analgesics, can cause nausea, vomiting, constipation, and the risk of dependency and overdose. It is important to use these medications under medical supervision to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several analgesic and anti-inflammatory drugs for the treatment of acute pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac are commonly used due to their efficacy in reducing pain and inflammation. Acetaminophen is another widely approved analgesic for acute pain, often used when NSAIDs are contraindicated. Opioids like tramadol and oxycodone have also been approved for more severe acute pain, though their use is generally limited due to potential for dependence and adverse effects. These medications are similar to those being studied in the MR-107A-02 trial for postoperative pain management.

What other types of research exist?

Promising novel alternatives for acute pain management in 2024 include AHR-5850, which is a highly potent non-steroidal anti-inflammatory compound with significant analgesic properties, and bimekizumab, a monoclonal antibody targeting IL-17A and IL-17F, which has shown efficacy in reducing pain and inflammation in preliminary studies.

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MR-107A-02 for Postoperative Pain

Phase 3

Waitlist Available

Research Sponsored by Mylan Specialty, LP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requirement for a primary unilateral bunionectomy

Has an American Society of Anesthesiologists Physical Status of I, II, or III

Must not have

History of GI bleeding or peptic ulcer disease

Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after randomization

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called MR-107A-02 to see if it can safely and effectively reduce pain in patients who have had bunion surgery.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects of MR-107A-02 aren't listed, common side effects for pain medications like Tramadol include nausea, dizziness, headache, drowsiness, vomiting, constipation, lack of energy, sweating and dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for a bunion on one foot.

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

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I experience moderate to severe pain after my nerve block wears off.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had stomach ulcers or bleeding in my digestive tract.

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

Select...

My body weight is less than 43 kg.

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I have been treated with MR-107A-02 before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.

Secondary study objectives

Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.

Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.

Other study objectives

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol

Summed Pain Intensity Difference (SPID) for tramadol versus placebo.

Side effects data

From 2022 Phase 2 trial • 111 Patients • NCT05317312

Blood bilirubin increased

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

MR-107A-02 1.25 mg Twice in a 24 Hour Period

MR-107A-02 5 mg Twice in a 24 Hour Period

MR-107A-02 15 mg Twice in a 24 Hour Period

Placebo Twice in a 24 Hour Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MR-107A-02Experimental Treatment1 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: TramadolActive Control2 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MR-107A-02

2023

Completed Phase 3

~530

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for acute pain include analgesics and anti-inflammatory agents. Analgesics, such as acetaminophen, work by inhibiting the synthesis of prostaglandins in the central nervous system, which helps reduce pain and fever. Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen and naproxen, inhibit cyclooxygenase (COX) enzymes, reducing the production of prostaglandins that cause inflammation, pain, and fever. These mechanisms are crucial for acute pain patients as they provide rapid relief from pain and inflammation, improving patient comfort and facilitating quicker recovery.

Analgesic agents. Pharmacology and application in critical care.