On January 31, 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigina, marketed under the brand name Journavx, as the first non-opioid analgesic for the treatment of moderate to severe acute pain in adults. This approval marks a significant milestone in pain management, offering a safer alternative to opioids, which are often associated with addiction risks. The drug is a 50-milligram oral tablet and represents the first new class of painkiller in more than two decades.
Mechanism of Action and Development
Suzetrigina operates by targeting a pain signaling pathway involving sodium channels in the peripheral nervous system, preventing pain signals from reaching the brain. This mechanism differs from traditional opioids, which dampen pain perception in the brain. The development of suzetrigina was inspired by a family in Pakistan with a genetic mutation that affects their pain receptors, allowing them to walk on hot coals without pain.
Clinical Trials and Efficacy
The efficacy of Journavx was evaluated in two randomized, double-blind, placebo-controlled trials involving participants with acute postsurgical pain. These trials included nearly 600 participants and demonstrated statistically significant pain reduction compared to a placebo. Participants were allowed to use ibuprofen as needed for additional pain relief. However, the drug's efficacy for chronic pain remains uncertain, as results varied across different studies.
Safety Profile and Adverse Reactions
The safety of Journavx was assessed in pooled trials involving 874 participants with moderate to severe acute pain. Common adverse reactions included itching, muscle spasms, increased creatine phosphokinase levels, and rash. The drug is contraindicated for concurrent use with strong CYP3A inhibitors, and patients are advised to avoid grapefruit products while taking the medication.
FDA Support and Public Health Impact
The FDA has long supported the development of non-opioid pain treatments as part of its overdose prevention framework. This includes issuing guidelines to encourage the development of non-opioid analgesics and providing grants to support clinical practice guidelines for managing acute pain conditions
Pricing and Availability
Vertex Pharmaceuticals, the developer of Journavx, has set a wholesale price of $15.50 per 50 mg tablet. The company also anticipates offering patient assistance programs to improve accessibility.
Regulatory Designations
Journavx received breakthrough therapy designation, fast track designation, and priority review from the FDA, underscoring its potential to address an unmet medical need. The approval was granted to Vertex Pharmaceuticals Incorporated.