The first oral medication of its kind, JOURNAVX™ (suzetrigine), has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderate to severe acute pain. Created by Vertex Pharmaceuticals, JOURNAVX is a game-changer in pain treatment; it provides effective and well-tolerated pain relief without the dangers of opioid addiction. Vertex has priced JOURNAVX at $15.50 per 50 mg pill in the U.S., with the FDA approving a twice-daily dosage regimen.
Acute pain, affecting over 80 million Americans annually and defined as lasting less than three months, presents a significant unmet need for improved management to enhance patient outcomes and alleviate economic and societal burdens. By offering an innovative, non-opioid solution, JOURNAVX underscores the shift toward safer, more effective pain management strategies. Vertex’s breakthrough sets the stage for further advancements in addressing both acute and chronic pain conditions without reliance on opioids.
A new class of pain treatment
JOURNAVX specifically targets the NaV1.8 voltage-gated sodium channel, an essential component in transmitting pain signals by nociceptors—neurons in the peripheral nervous system (PNS) that sense pain. Instead of targeting the central nervous system (CNS), JOURNAVX blocks these pain signals in the PNS, protecting users from the addiction and side effects associated with opioids and other traditional painkillers. This unique mechanism makes JOURNAVX the first approved medication in a new class of non-opioid pain relievers.
The FDA’s approval follows two rigorous, randomized, double-blind clinical trials evaluating JOURNAVX’s efficacy in patients undergoing abdominoplasty and bunionectomy. Participants in these studies experienced statistically significant pain reduction compared to those receiving a placebo. Patients were also allowed to use ibuprofen as a rescue medication for breakthrough pain.
The safety profile of JOURNAVX was derived from data on 874 participants in these trials and supported by a single-arm, 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.
Vertex advances research on suzetrigine for neuropathic pain
Vertex Pharmaceuticals is expanding its exploration of suzetrigine’s potential to treat neuropathic pain, with promising clinical developments already underway. In October 2024, the company reported positive results from a Phase II study evaluating suzetrigine in individuals with painful lumbosacral radiculopathy (LSR), characterized by nerve root compression and radiating pain. The study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in pain scores as measured by the Numeric Pain Rating Scale (NPRS).
Building on this progress, Vertex launched a pivotal program earlier in 2024 to assess suzetrigine’s efficacy in painful diabetic peripheral neuropathy (DPN), another form of peripheral neuropathic pain (PNP). This study remains ongoing, reflecting the company’s commitment to broadening therapeutic options for patients with challenging neuropathic pain conditions.
All of these initiatives show how Vertex is trying to cement suzetrigine’s position as a go-to non-opioid pain treatment by establishing it as a flexible option for a range of neuropathic pain syndromes.
