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04 February 2025
FDA Approves JOURNAVX™, a New Non-Opioid Pain Medication
The U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), the first oral medication of its kind, for treating adults with moderate to severe acute pain. Developed by Vertex Pharmaceuticals, JOURNAVX represents a significant advancement in pain management by providing effective and well-tolerated relief without the risk of opioid addiction. Priced at $15.50 per 50 mg pill in the U.S., the medication has been approved for a twice-daily dosage regimen.
Acute pain affects over 80 million Americans each year and is defined as lasting less than three months. Addressing this widespread issue with improved treatment options is essential to enhancing patient outcomes and reducing economic and societal burdens. JOURNAVX introduces an innovative, non-opioid solution, reflecting a broader shift toward safer and more effective pain management strategies. This breakthrough paves the way for further advancements in treating both acute and chronic pain without opioid dependence.
JOURNAVX works by specifically targeting the NaV1.8 voltage-gated sodium channel, a crucial component in transmitting pain signals through nociceptors—neurons in the peripheral nervous system that detect pain. Unlike traditional painkillers that act on the central nervous system, JOURNAVX blocks these signals at the peripheral level, minimizing the risks associated with opioid use. This distinct mechanism makes it the first approved medication in a new class of non-opioid pain relievers.
The FDA's approval follows rigorous evaluation in two randomized, double-blind clinical trials involving patients undergoing abdominoplasty and bunionectomy. Participants who received JOURNAVX experienced significantly greater pain reduction compared to those on a placebo, with ibuprofen available as a rescue medication for breakthrough pain.
The safety profile of JOURNAVX was assessed using data from 874 participants in these trials, supported by a separate open-label study involving 256 patients with various acute pain conditions. The most commonly reported side effects included itching, muscle spasms, elevated creatine phosphokinase levels, and rash.
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