FDA approves non-opioid analgesic.
On January 30, 2025, the United States FDA approved medication Journavx (suzetrigine). It is the first of its kind: a non-opioid, oral pain medication for use in adults with moderate to severe acute pain. Journavx works by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system between the site of injury and the brain.
When a person experiences acute pain, the human body creates signals that travel through the nervous system. It’s not until those signals reach the brain that a person actually feels pain. Because Journavx blocks the pain signals in the peripheral system and not in the brain itself, it is able to reduce pain without the potential of adverse events and side effects like those of opioids.
Prior to FDA approval, there were two randomized, double-blind, placebo- and active-controlled trials of Journavx. Participants in the trials had acute surgical pain following either abdominoplasty or bunionectomy, depending on the trial. Both trials revealed that participants using Journavx had a marked decrease in pain compared to placebo. The most common adverse reactions in the trials were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
Journavx dosing begins with two 50mg tablets (loading dose), followed by one 50mg tablet every twelve hours, beginning twelve hours after the loading dose. Note that the use of Journavx was not studied for use beyond fourteen days. The wholesale acquisition cost in the U.S is $15.50 per 50mg tablet.
Optum Rx pharmacy benefit manager (PBM), owned by UnitedHealth Group, is the first major PBM to place Journavx on some commercial formularies as a Tier 3 medication. This is an interim decision by the company until a formal review can be completed. Tier 3 medications include higher-cost brand name drugs and some generic drugs. Other major PBMs, including CVS, Humana, and Cigna, either declined or didn’t immediately respond to requests for updates on their coverage plans.
Article by Stacy Schumacher, RN, BSN, CMCN, Managed Care Specialist. The following sources were used as reference material for this article: