The US Food and Drug Administration’s approval of suzetrigine at the start of 2025 was a breakthrough moment for pain management. Developed by Vertex Pharmaceuticals, it is marketed as Journavx for the treatment of adults with moderate-to-severe acute pain.
Suzetrigine marks the first approval of a novel class of non-opioid pain medications in more than two decades, and is pioneering a new paradigm in which potent pain relief does not have to come with a trade-off of dependency.
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Opioids have been the cornerstone of pain management for more than a century. Their dominance grew throughout the 20th century and became the standard of care for moderate to severe pain. However, recent decades have revealed the serious risks of addiction and long-term dependency. In particular, the US faces a growing opioid addiction: data from the US Centers for Disease Control and Prevention indicates that 80,000 people died from opioid overdoses in 2023 alone, revealing the devastating consequences of opioid abuse.
The root of the problem is the mechanism of action of opioids, which bind to receptors in the brain and spinal cord to block pain and elicit feelings of euphoria. This activates the brain’s reward system and can quickly lead to dependency. Unlike opioids, suzetrigine disrupts the transmission of pain signals from the body to the brain without affecting the brain itself, by inhibiting the NaV1.8 voltage-gated sodium channels predominantly found in peripheral pain-sensing neurons. This allows for effective pain relief without eliciting the feeling of euphoria, greatly limiting the risk of addiction.
Suzetrigine is the first approved oral Nav1.8 inhibitor, and many medical professionals believe this could be a game-changer, arriving at a pivotal time in the battle against the opioid crisis. Insight from GlobalData’s Trials Intelligence Platform reveals that suzetrigine’s efficacy and safety were evaluated in two pivotal Phase III randomised, double-blind, placebo-controlled and active-controlled trials involving patients undergoing abdominoplasty and bunionectomy surgeries. Suzetrigine demonstrated a statistically significant improvement in pain compared to placebo, the incidence of severe toxicities was low, and no significant adverse effects were observed.
These results will hopefully be replicated in ongoing studies, which will allow suzetrigine to move beyond acute pain to address chronic peripheral neuropathic pain (PNP) conditions. According to GlobalData’s Trials Intelligence Platform, Vertex Pharmaceuticals has 11 planned or ongoing trials covering PNP conditions, including ongoing Phase III trials for diabetic peripheral neuropathy.
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By GlobalDataNon-opioid alternatives are long overdue. Insights from GlobalData’s Trials Intelligence Platform show that trials investigating non-opioid painkillers increased in the decade since 2016, but numbers have begun to decline once again and remain neck and neck with opioid painkiller trials (Figure 1). The success of suzetrigine will hopefully revive the field of non-opioid pain management as the goal moves beyond just relieving pain to doing so safely, without perpetuating cycles of harm.
