VX-548 for Acute Pain
Recruiting at 14 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for VX-548 in humans?
How does the drug VX-548 for acute pain differ from other treatments?
VX-548 is unique because it is a novel treatment option for acute pain, potentially involving a mechanism similar to N-type calcium channel blockers like ω-conotoxin MVIIA, which are known for their potent analgesic effects by inhibiting pain-related neurotransmitter release in the nervous system.678910
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Your body mass index (BMI) is between 18.0 and 40.0.
If you had surgery, and you have moderate or severe pain at the surgery site, and the pain is rated 4 or higher on a scale.
Your body mass index (BMI) is between 18 and 40.
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Exclusion Criteria
If you had surgery for the same problem before, you can join only if the previous surgery was on the opposite limb or organ.
Surgical participants with history of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
Surgical participants with history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive VX-548 every 12 hours for up to 14 days
2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- VX-548
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Suzetrigine (SUZ)Experimental Treatment1 Intervention
Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Trials
267
Recruited
36,100+
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
Published Research Related to This Trial
A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.
The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.Smith, SM., Wang, AT., Katz, NP., et al.[2023]
In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).
Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse events in phase one studies: a study in 430 healthy volunteers.Sibille, M., Deigat, N., Olagnier, V., et al.[2019]
In a pilot survey of 22 older adults with chronic pain, gastrointestinal adverse drug events (ADEs) were the most commonly reported, with upset stomach being the most frequent issue, affecting 31.8% of participants.
Many older adults self-manage their analgesic-related ADEs without consulting their healthcare provider; 54.5% contacted their physician, while others changed their medication or stopped taking it altogether, highlighting the need for better communication about ADE management in primary care.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study.McDonald, DD., Coughlin, S., Jin, C.[2019]
Citations
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]
Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]
Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. [2019]
Safety concerns reported by consumers, manufacturers and healthcare professionals: A detailed evaluation of opioid-related adverse drug reactions in the FDA database over 15 years. [2021]
Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10-year French vigilances retrospective study. [2023]
The novel N-type calcium channel blocker, AM336, produces potent dose-dependent antinociception after intrathecal dosing in rats and inhibits substance P release in rat spinal cord slices. [2019]
Effect of ω-conotoxin MVIIA and Phα1β on paclitaxel-induced acute and chronic pain. [2016]
Expert panel consensus recommendations for the pharmacological treatment of acute pain in the Middle East region. [2017]
A fusion protein of conotoxin MVIIA and thioredoxin expressed in Escherichia coli has significant analgesic activity. [2019]
Nicotinic Acetylcholine Receptors Mediate the Suppressive Effect of an Injection of Diluted Bee Venom into the GV3 Acupoint on Oxaliplatin-Induced Neuropathic Cold Allodynia in Rats. [2018]
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