Technology and Scienceupdated 33m ago2 min read
FDA Approves Journavx (Suzetrigine) First-In-Class Non-Opioid Pain Reliever For Acute Pain
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FDA approves Journavx (suzetrigine) as first-in-class non-opioid for moderate-to-severe acute pain in adults. Pill works by inhibiting pain signaling via peripheral sodium channels before brain processing.
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FDA okays Journavx
The Food and Drug Administration approved Journavx (suzetrigine) on Jan. 30 as a first-in-class non-opioid pain reliever for adults with moderate-to-severe acute pain.
Vertex Pharmaceuticals said Journavx is an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor, and the FDA described it as targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system before pain signals reach the brain.
The FDA framed the approval as an “important public health milestone in acute pain management,” and Jacqueline Corrigan-Curay, M.D., acting director of the FDA's Center for Drug Evaluation and Research, said a non-opioid pain reliever “offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
The approval also arrived as the United States grapples with opioid risks, and NBC News reported that Dr. Richard Rosenquist said “anyone who gets exposed to opioids has the potential to have dependence on them.”
How it differs
NBC News explained that opioids work by stimulating opioid receptors in the brain and that the brain floods with the neurotransmitter dopamine, creating feelings of euphoria and activating the brain's reward system.
NBC News said suzetrigine works in a different way by blocking the pain signal from traveling to the brain, with the signal triggered by sodium rushing into the nerve ending.
Michael Schatman, a clinical instructor at NYU Grossman School of Medicine, said, “I think in acute pain this drug has great promise. This is something that could be opioid-sparing, and we need more tools in our armory for pain.”
Dr. Richard Rosenquist also told NBC News that “Right now all the evidence suggests this has no addiction potential at all,” and he added that it is “no different than Tylenol or ibuprofen in terms of addiction potential.”
Access, trials, and stakes
Vertex said Journavx will cost $15.50 per 50 milligram pill, and AARP reported the list price as $15.50 per 50 milligram pill.
“Journavx has a list price of $15.50 per 50 milligram pill.”
Vertex also said the FDA approved Journavx twice-daily for adults with moderate-to-severe acute pain, and Vertex described the drug as “an effective and well-tolerated medicine without evidence of addictive potential” indicated across all types of moderate-to-severe acute pain.
NBC News reported that in phase 3 clinical trials patients who had tummy tucks or bunion surgery received suzetrigine every 12 hours, an opioid hydrocodone plus Tylenol every six hours, or placebo for 48 hours after the operations.
Dr. David Rind, chief medical officer at the Institute for Clinical and Economic Review, said the results “do not tell us a lot about how much of a rescue medication was used,” and he added, “We don’t know if they would have had higher pain reduction if they had just taken an NSAID from the start.”