What side effects are associated with this type of intervention?

Common treatments for acute pain, such as NSAIDs (e.g., ibuprofen, diclofenac) and acetaminophen, are generally well-tolerated but can have side effects. NSAIDs may cause gastrointestinal issues like ulcers and bleeding, kidney dysfunction, and increased cardiovascular risk. Acetaminophen is usually safe but can lead to liver toxicity, especially at high doses. Other non-opioid analgesics, like celecoxib, may have similar gastrointestinal and cardiovascular risks. It is important to use these medications as directed to minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of acute pain, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, acetaminophen, and opioids such as morphine and oxycodone. These medications primarily provide symptomatic relief by targeting general pain pathways. More recently, there has been interest in developing drugs that target specific pain pathways, such as nerve growth factor inhibitors and other novel analgesics. However, no specific mention of FDA-approved drugs directly analogous to VX-548, which targets pain pathways, was found in the provided context.

What other types of research exist?

Promising novel alternatives to VX-548 for acute pain management include: <ol> <li>Single-dose intravenous diclofenac, which has shown efficacy in acute postoperative pain.</li> <li></li> </ol> Single-dose intravenous ketorolac, another NSAID with proven effectiveness in acute pain settings. 3. Gabapentinoids like pregabalin and gabapentin, which are used in multimodal analgesic protocols, though they come with risks of respiratory depression and potential for abuse. 4. Investigational drugs targeting nerve growth factor, which are being developed to address different pain pathways. These alternatives offer various mechanisms of action and delivery methods, providing options for personalized pain management strategies.

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VX-548 for Post-Bunionectomy Pain

Phase 3

Waitlist Available

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing VX-548, a new medication, to see if it can help reduce pain in patients who have had bunion surgery by blocking or reducing pain signals.

Who is the study for?

This trial is for people who are clear-headed and can follow instructions, scheduled to have a specific type of foot surgery (bunionectomy) under certain anesthesia. They must have followed pain management guidelines before and after surgery. Those with previous foot surgeries, recent heart rhythm problems needing treatment, or any surgery in the last month cannot join.

What is being tested?

The study tests VX-548's effectiveness and safety in managing acute pain post-bunionectomy compared to HB/APAP (a known pain reliever) and placebos that look like each drug but contain no active ingredients.

What are the potential side effects?

While the side effects of VX-548 aren't specified here, typical side effects for acute pain medications may include nausea, dizziness, headache, stomach upset or bleeding risks. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: VX-548Experimental Treatment2 Interventions

Participants will be randomized to receive VX-548.

Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP)Active Control2 Interventions

Participants will be randomized to receive HB/APAP.

Group III: PlaceboPlacebo Group2 Interventions

Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-548

2022

Completed Phase 3

~3790

Placebo (matched to HB/APAP)

2021

Completed Phase 3

~2770

Do I qualify?Apply below to find out

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

Common treatments for acute pain include NSAIDs, which inhibit COX enzymes to reduce inflammation and pain, and acetaminophen, which likely works through central COX inhibition and endocannabinoid modulation. Investigational drugs like VX-548 target specific pain pathways, potentially offering more effective and safer pain relief. Understanding these mechanisms helps in choosing the best treatment, ensuring effective pain management while minimizing side effects.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.