Novel Drug & Emergent Therapeutics | Pharmaceuticals | Pain Management
FDA Approves JOURNAVX™ (suzetrigine): A First-in-Class Non-Opioid Analgesic for Acute Pain
Time to read: 01:09
Originally published: 31 January 2025
Source: FDA Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDP001
Category: Pain
Crossreference: Neurology
Category tags: pain, pain management, opioids, analgesia
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Approved |
The U.S. Food and Drug Administration (FDA) has approved JOURNAVX ™ (suzetrigine) 50 mg oral tablets, the first non-opioid analgesic in a new class of pain management drugs for moderate to severe acute pain in adults.
JOURNAVX™ is a highly selective NaV1.8 pain signal inhibitor that targets voltage-gated sodium channels found in peripheral pain-sensing neurons (nociceptors). By blocking these pain signals before they reach the brain, JOURNAVX™ provides effective pain relief without the risks associated with opioids, including addiction.
JOURNAVX™ received Breakthrough Therapy, Fast Track, and Priority Review designations, reinforcing its significance in pain management.
The approval supports the FDA’s Overdose Prevention Framework, which prioritizes non-opioid pain treatments. FDA Acting Director Jacqueline Corrigan-Curay emphasized that this milestone offers patients an alternative to opioids while maintaining effective pain relief.
The efficacy of JOURNAVX™ was evaluated in two randomized, double-blind, placebo- and active-controlled trials for acute pain following abdominoplasty and bunionectomy.
Both studies demonstrated significantly greater pain reduction compared to placebo, with ibuprofen available as a rescue medication.
Safety data from 874 participants showed common side effects, including itching, muscle spasms, rash, and elevated creatine phosphokinase levels. It should be noted that the drug is contraindicated in the presence of strong CYP3A inhibitors.
Vertex is currently evaluating the efficacy of suzetrigine for patients with painful diabetic peripheral neuropathy. It plans to advance its pivotal program to evaluate the use of suzetrigine in patients with painful lumbosacral radiculopathy, pending discussions with regulators.
Access the Press Releases
30 January 2025 | FDA | FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
30 January 2025 | Vertex | Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
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