Suzetrigine for Chronic Pain
Suzetrigine is NOT approved or recommended for chronic pain management—it is FDA-approved exclusively for moderate to severe acute pain in adults, with a maximum treatment duration of 14 days. 1, 2
Current FDA Approval and Limitations
- Suzetrigine (JOURNAVX™) received FDA approval on January 30,2025, specifically for moderate to severe acute pain only 1, 3
- The drug is administered as a 100 mg loading dose followed by 50 mg every 12 hours for up to 14 days or until pain resolution 1, 2
- No studies have evaluated suzetrigine's efficacy, safety, or addiction potential for chronic pain management 4
- All current clinical trials are limited to short-duration treatment of acute surgical and non-surgical pain conditions 4, 2
Mechanism and Rationale
- Suzetrigine is a highly selective NaV1.8 voltage-gated sodium channel inhibitor that blocks pain signal transmission in peripheral sensory neurons 1, 5
- Unlike opioids, it does not produce CNS effects, euphoria, or addictive potential because NaV1.8 is not expressed in the brain 5, 2
- The drug represents the first non-opioid analgesic approved in over two decades and the first in a new therapeutic class 5, 3
Evidence-Based Chronic Pain Management
For chronic pain, established guidelines recommend a structured approach:
First-Line Non-Pharmacologic Therapies
- Cognitive behavioral therapy (CBT) is strongly recommended for chronic pain management (promotes adaptive behaviors and addresses maladaptive pain-related thoughts) 6
- Physical and occupational therapy are recommended as foundational treatments 6
- Yoga is recommended specifically for chronic neck/back pain, headache, rheumatoid arthritis, and musculoskeletal pain 6
- Exercise therapy reduces pain and improves function in osteoarthritis, low back pain, and fibromyalgia 6
First-Line Pharmacologic Therapies for Chronic Pain
For neuropathic pain:
- Gabapentin is the recommended first-line oral treatment (titrate to 1800-3600 mg/day in divided doses) 6, 7
- Pregabalin is an alternative for inadequate gabapentin response or post-herpetic neuralgia 6, 7
- Capsaicin 8% topical patch provides up to 12 weeks of relief with a single 30-minute application 6, 7
For musculoskeletal pain:
- Acetaminophen is first-line for osteoarthritis and low back pain (avoid >3-4 grams/day due to hepatotoxicity risk) 6
- NSAIDs are effective but carry gastrointestinal, renal, and cardiovascular risks that increase with duration and dose 6
For refractory cases:
- SNRIs (duloxetine) or tricyclic antidepressants can be added for neuropathic pain or fibromyalgia 6
- Multimodal therapy combining pharmacologic and non-pharmacologic approaches is more effective than single modalities 6
Critical Caveats
- Suzetrigine has not been studied beyond 14 days of treatment, making its role in chronic pain completely unknown 4, 2
- The drug appears less potent than hydrocodone-acetaminophen for acute pain, raising questions about efficacy for chronic conditions 4
- Avoid suzetrigine in severe hepatic impairment (Child-Pugh Class C) and renal impairment with eGFR <15 mL/min 1
- Dose reduction is required for moderate hepatic impairment due to increased drug exposure 1
Clinical Algorithm for Chronic Pain
- Initiate non-pharmacologic therapies first: CBT, physical therapy, and condition-specific exercise programs 6
- Add first-line pharmacotherapy based on pain type:
- For inadequate response after 4-8 weeks: Add pregabalin, SNRIs, or tricyclics 6, 7, 8
- Consider topical agents: Capsaicin 8% patch for localized neuropathic pain 6, 7
- Reassess regularly with multidisciplinary team involvement and functional goals 6
Suzetrigine has no established role in this chronic pain algorithm and should not be used off-label until long-term efficacy and safety data become available.