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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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The most common adverse reactions include itching, muscle spasms, increased blood level of creatine kinase, and rash.[1][2]

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 numerical scale used to rate pain.[7][8] This pain relief matched that of a combination of hydrocodone and paracetamol (acetaminophen) (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen).[8][9]

Suzetrigine suppresses pain at the same level as opioids, but without the risks of addiction, sedation, or overdose.[10]

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]

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Contraindications

Concomitant use of suzetrigine with strong CYP3A 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 an adverse grapefruit–drug interaction.[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.[11] The FDA granted priority review, fast track, and breakthrough therapy designations to the application for suzetrigine.[2][11] 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][10]

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Society and culture

Suzetrigine was originally approved for medical use in the United States in January 2025.[2]

Names

Suzetrigine is the international nonproprietary name.[12]

Suzetrigine is sold under the brand name Journavx.[1][2]

References

Further reading

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