Journavx (Suzetrigine): Non-Opioid Pain Treatment Appoved by FDA

Last Updated on March 8, 2025 by Joseph Gut – thasso

March 07, 2025 – On January 30, 2025, the U.S. Food and Drug Administration (FDA) approved Journavx (Suzetrigine), 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx (Suzetrigine) reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery. Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.

“The approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx (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. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx (Suzetrigine) compared to placebo.

The safety profile of Journavx (Suzetrigine) is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions. The most common adverse reactions in study participants who received Journavx (Suzetrigine) were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.

According to FDA’s drug label of the medication, Journavx (Suzetrigine) is contraindicated for concomitant use with strong CYP3A inhibitors. Also, the dosing of Journavx (Suzetrigine) has to be carefully followed when used in patients taking drugs that are substrates of CYP3A ( see an overview on such substrates (and inhibitors / inducers too) here in the so-called Flockhart-Table). Overall, correct dosing of Journavx (Suzetrigine) may be no easy task given the overall extensive  genetic variability underneath the CPP3A gene and its influence on CYP3A-dependent metabolic capacity of patients. Additionally, patients should avoid food or drinks containing grapefruit when taking Journavx (Suzetrigine).

After having a couple of blogs here, here, here, and here, dealing with aspects the opioid crisis, thasso is excited to finally present here an article on a promising alternative of pain relief in the form of Journavx (Suzetrigine).

See here a short sequence on the non opioid medication Journavx (Suzetrigine):

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