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Suzetrigine

Non-opioid analgesic drug From Wikipedia, the free encyclopedia

Suzetrigine
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Suzetrigine, sold under the brand name Journavx, is a medication used for pain management.[1][2] It is a small-molecule non-opioid analgesic that works as a selective inhibitor of Nav1.8-dependent pain-signaling pathways in the peripheral nervous system.[3][4] It is not addictive. Suzetrigine is taken by mouth.[1]

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Suzetrigine was developed by Vertex Pharmaceuticals.[5] It was approved for medical use in the United States in January 2025.[2][6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this class of medicines.[2]

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Medical uses

Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults.[1][2]

Efficacy

In clinical studies conducted through 2024, suzetrigine reduced pain typically from 7 to 4 on the standard numeric scale used to rate pain.[7][8] The efficacy of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.[2] Both trials found that suzetrigine reduced pain more effectively than placebo.[2]

However, in clinical studies, no superiority over hydrocodone and paracetamol (acetaminophen) in terms of pain reduction was shown.[9] The approval of Journavx was met with criticism from medical professionals, where its efficacy was deemed inferior to opioid analgesics.[10] Moreover, there are no studies comparing suzetrigine with full-dose opioids, and its cost-effectiveness is disputed.[11] Most patients in clinical trials required rescue NSAID administration. An important drawback compared to opioids is that suzetrigine exhibits CYP3A4-mediated drug interactions and there is limited long-term data regarding its use.[12]

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Contraindications

Concomitant use of suzetrigine with strong CYP3A4 inhibitors is contraindicated.[1][2]

Adverse effects

Common adverse effects of suzetrigine may include itching, rash, muscle spasms, and increased levels of creatine kinase.[2] Mild side effects may include nausea, constipation, headache, and dizziness.[7][8] As of 2024, long-term safety and side effects remain undetermined.[8]

In preliminary research, suzetrigine had no serious neurological, behavioral, or cardiovascular effects.[3]

Interactions

Consuming grapefruit while using suzetrigine may cause adverse grapefruit–drug interactions.[1][2]

Mechanism of action

Suzetrigine operates on peripheral nerves, avoiding the addictive potential of opioids, which affect the central nervous system.[3][4][7] Unlike opioid medications, which reduce pain signals in the brain, suzetrigine works by closing sodium channels in peripheral nerves, inhibiting pain-signaling nerves from transmitting painful sensations to the brain.[3][4][7]

In pharmacological studies, suzetrigine selectively inhibited Nav1.8 channels, but not other voltage-gated sodium channels, and bound to a unique site on these sodium channels with a novel allosteric mechanism, by binding to the channel's second voltage-sensing domain, thereby stabilizing the closed state, causing tonic inhibition. It exerts its action on dorsal root ganglia.[3]

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History

Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials.[5] The company announced in July 2024 that the FDA had accepted a New Drug Application for suzetrigine.[13] The FDA granted priority review, fast track, and breakthrough therapy designations to the application for suzetrigine.[2][13] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals, making it the first non-opioid pain medication to be approved by the FDA in two decades.[2][14]

The manufacturer engaged in lobbying activity promoting non-opioid pain treatment and supporting the NO PAIN Act (Non-Opioids Prevent Addiction In the Nation Act).[15]

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References

Further reading

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