What side effects are associated with this type of intervention?

Common treatments for pain, such as opioids, NSAIDs, gabapentinoids, and topical agents, have various side effects. Opioids can cause constipation, nausea, drowsiness, and risk of addiction and overdose. NSAIDs may lead to gastrointestinal issues, cardiovascular risks, and kidney damage. Gabapentinoids like gabapentin and pregabalin can cause dizziness, fatigue, and peripheral edema. Topical agents like capsaicin and lidocaine may cause local skin irritation and burning sensations. Each treatment has a unique side effect profile that should be considered when managing pain.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of pain, including opioid analgesics like tramadol, which is recommended for moderate to severe refractory chronic pain. Additionally, gabapentinoids such as gabapentin and pregabalin have been used for neuropathic pain, although their efficacy in certain conditions like chemotherapy-induced peripheral neuropathy (CIPN) is not well-supported. Anti-NGF agents like tanezumab and fasinumab have shown some promise in reducing pain and improving function in osteoarthritis but have raised safety concerns, leading to discontinuation of some trials. While specific information on FDA-approved Selective NaV1.8 Inhibitors like VX-548 is not provided, these examples illustrate the range of pharmacologic approaches to pain management.

What other types of research exist?

Promising novel alternatives to VX-548 for pain treatment include: 1) CHF3381, an NMDA receptor antagonist and MAO-A inhibitor, which attenuates secondary hyperalgesia. 2) New Nav1.7 inhibitors, such as QLS-81, which show potent anti-nociceptive activity. 3) TRPV1 antagonists, which inhibit nociceptive signal transmission and are designed to be CNS-penetrant and orally available. 4) Peptide toxins targeting NaV1.7, like modified HwTx-IV analogues, which have shown improved selectivity and efficacy.

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VX-548 for Acute 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

No Placebo-Only Group

Summary

This trial is testing VX-548, a new drug aimed at reducing sudden, severe pain. It focuses on patients who need quick pain relief. VX-548 works by blocking pain signals from reaching the brain.

Who is the study for?

This trial is for adults with a BMI between 18.0 and 40.0 who are experiencing new, moderate to severe acute pain, rated ≥4 on the numeric scale. It includes both surgical patients with postoperative pain and non-surgical individuals with new pain not related to any known condition.

What is being tested?

The study is testing VX-548's safety and effectiveness in treating acute pain. Participants will receive VX-548 under controlled conditions to assess how well it manages their pain symptoms.

What are the potential side effects?

While specific side effects of VX-548 are not listed here, common side effects from medications treating acute pain may include nausea, dizziness, headache, or drowsiness. Individual reactions can vary.

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VX-548Experimental Treatment1 Intervention

Participants will receive VX-548 every 12 hours (q12h) up to 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-548

2022

Completed Phase 3

~3580

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 pain work through various mechanisms. Selective NaV1.8 inhibitors like VX-548 target specific sodium channels involved in pain signaling, potentially offering targeted pain relief with fewer side effects. Gabapentinoids, such as gabapentin and pregabalin, modulate calcium channels to reduce neurotransmitter release and alleviate neuropathic pain. Opioids bind to opioid receptors in the brain and spinal cord, altering pain perception but carry risks of addiction and tolerance. NSAIDs inhibit cyclooxygenase enzymes, reducing inflammation and pain. Cannabinoids interact with the endocannabinoid system to modulate pain and inflammation. Understanding these mechanisms helps tailor pain management to individual needs, optimizing efficacy and minimizing adverse effects.

Central Nervous System Targets: Supraspinal Mechanisms of Analgesia.Analgesic agents. Pharmacology and application in critical care.