Suzetrigine Indications
Suzetrigine is FDA-approved exclusively for the treatment of moderate to severe acute pain in adults. 1, 2
Approved Indication
Moderate to Severe Acute Pain in Adults
Suzetrigine received FDA approval on January 30,2025, as the first-in-class selective NaV1.8 inhibitor for managing moderate to severe acute pain in adult patients. 1, 2 This represents a novel non-opioid therapeutic option that works by selectively blocking voltage-gated sodium channel 1.8 (NaV1.8) in peripheral pain-sensing neurons. 3
Clinical Applications Demonstrated in Trials
The medication has shown safety and effectiveness across multiple acute pain scenarios:
- Surgical pain: Postoperative pain management following various surgical procedures 4, 5
- Non-surgical acute pain: New-onset moderate to severe pain presenting to medical facilities 4
- Broad applicability: Successfully used in 256 participants with diverse surgical and non-surgical acute pain conditions 4
Dosing Regimen
The approved dosing schedule is:
- Loading dose: 100 mg initially
- Maintenance: 50 mg every 12 hours
- Duration: Up to 14 days or until pain resolution, whichever occurs first 4
Mechanism and Safety Profile
Suzetrigine works through a unique allosteric mechanism, binding to the second voltage sensing domain (VSD2) of NaV1.8 channels to stabilize the closed state and reduce pain signal transmission. 3 The drug demonstrates exceptional selectivity (≥31,000-fold) against all other sodium channel subtypes and 180 other molecular targets. 3
Critical safety advantages over opioids:
- No CNS activity or central side effects 4, 3
- No addictive potential or dependence 3, 2
- No euphoria or brain excitation 2
- Most adverse events were mild (27.7%) or moderate (8.2%) in severity 4
Patient Satisfaction
In the phase 3 single-arm study, 83.2% of participants rated suzetrigine's effectiveness as good, very good, or excellent on patient global assessment. 4
Important Limitations
Suzetrigine is NOT indicated for:
- Chronic pain conditions (no approval or data)
- Neuropathic pain as a primary indication (though one case report showed benefit in hereditary neuropathy) 5
- Pediatric patients (approved only for adults) 1
- Mild pain (approved specifically for moderate to severe pain) 1
The medication represents the first approved member of a new therapeutic class of selective NaV1.8 pain signal inhibitors, offering a non-opioid alternative for multimodal analgesia in acute pain management. 2