US Approves Non-Opioid Painkiller: What Is It, and How Does It Work?

How does Journavx treat acute pain?

The US Food and Drug Administration (FDA) announced its approval of a non-opioid treatment for moderate–severe acute chronic pain. The drug, Journavx™ (suzetrigine), represents the first new class of pain management medicine to be approved in the US since 1998. 

Journavx, developed by Vertex Pharmaceuticals Incorporated, is a first-of-its-kind non-opioid pain medication. The drug works by selectively targeting a specific voltage-gated sodium channel, Na_V1.8, expressed in pain-sensing neurons (nociceptors) in the peripheral nervous system (PNS), not the brain, which is part of the central nervous system (CNS).

This mechanism of action is key to Journavx’s non-addictive properties – by inhibiting Na_V1.8, the drug blocks pain signals generated in the periphery from reaching the brain.

Opioids, in contrast, interact directly with opioid receptors in the brain to block the perception of pain. In doing this, they can also trigger the brain’s powerful reward systems that create a feeling of euphoria, contributing to the risk of addiction and opioid use disorder (OUD).

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Journavx’s journey to approval

Vertex’s application to the FDA successfully received Breakthrough Therapy, Fast Track and Priority Review designations.

Twice-daily oral 50mg doses of Journavx for adults experiencing moderate-to-severe acute pain have now been approved by the FDA. This approval is based on the organization’s evaluation of pooled data from two randomized, double-blind, placebo- and active-controlled trials, each recruiting ~1,000 patients experiencing moderate to severe acute pain after surgery.

In one trial patients had undergone an abdominoplasty – commonly known as a “tummy tuck” – and in the other trial, they had a bunionectomy, a procedure where bunions are surgically removed. Across both trials, Journavx significantly reduced pain compared to placebo.

Vertex also submitted safety profile data from an additional study of 256 surgical and non-surgical patients that were experiencing moderate–severe acute pain. Across the trials conducted by Vertex, the most commonly reported side effects were itching, muscle spasms, increased levels of creatine phosphokinase in the blood, and a rash.

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, M.D., M.P.H., associate physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering committee member. “I believe Journavx could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”

Is Jornavx cost-effective?

Vertex has priced Journavx at $15.50 per pill, or $31 per day of treatment. In December 2024, the Institute for Clinical and Economic Review published a draft evidence report on the drug’s effectiveness and value. The report stated that Journavx is “slightly cost-saving” based on its potential to “avert cases of opioid use disorder”, which “has negative impacts on mortality and quality of life and is associated with excess health care costs”.

The drug’s approval represents decades of advancement in pain research and likely marks the beginning of a new era of pain treatment. While Journavx is only approved for acute to moderate pain at this stage, Vertex is actively studying the drug’s effectiveness in conditions that can cause debilitating, long-term pain and lack efficacious treatments, such as painful diabetic peripheral neuropathy and painful lumbosacral radiculopathy. Early results have shown some promise, but larger-scale studies are required.