If approved, suzetrigine would represent the first new drug class for acute pain in more than 20 years.
In one of the year’s most closely watched decisions, the FDA is expected to render a verdict Thursday on Vertex’s suzetrigine, which—if approved—would provide the first new mechanism for the treatment of acute pain in over two decades.
The action date comes just a week after Purdue Pharma and the Sackler family agreed to pay $7.4 billion to settle lawsuits stemming from the company’s opioid-based painkiller OxyContin. Vertex is one of several companies looking to bring non-opioid options to the market in the midst of a still-ongoing opioid epidemic that kills tens of thousands per year.
Suzetrigine is an orally available pain signal inhibitor that selectively targets the NaV1.8 voltage-gated sodium channel, a genetically validated pain target found on peripheral neurons. NaV1.8 is believed to play a role in sensing pain and transmitting signals back to the central nervous system.
Vertex is supporting suzetrigine’s New Drug Application with data from two Phase II and three Phase III studies, including the NAVIGATE 1 and NAVIGATE 2 trials, which assessed the drug’s analgesic efficacy in patients who had undergone bunion removal or tummy tuck surgery (bunionectomy and abdominoplasty, respectively). In these late-stage trials, suzetrigine had greater efficacy in patients following abdominoplasty, improving pain scores by 48.4 points, while patients undergoing bunionectomy saw their pain scores lowered by 29.3 points.
Not all of suzetrigine’s results have been so robust, however. In December, Vertex revealed data from a Phase II trial studying the drug in nearly 220 patients with lumbosacral radiculopathy, a disorder that causes pain the lower back and hips, often radiating down the leg. At 12 weeks, patients taking Vertex’s drug saw a mean reduction of 2.02 points in the numeric pain rating scale (NPRS). While this result met the study’s primary endpoint, the placebo group also saw a 1.98-point drop in mean NPRS score, giving analysts pause.
In an investor note at the time, Truist Securities analysts wrote that the results were “worse than anticipated as no numeric separation can be seen between [suzetrigine] and [placebo] arms.”
An approval for suzetrigine would generate momentum for a non-opioid pain space that also includes companies like Tris Pharma, Latigo Biotherapeutics and SiteOne Therapeutics. Last week, Tris reported positive Phase III data for its non-opioid painkiller, cebranopadol, which showed strong efficacy as well as a solid safety profile in patients who had just undergone abdominoplasty. Meanwhile, Latigo launched in February 2024, raising $135 million in a series A round for its NaV1.8 inhibitor, LTG-001, and SiteOne secured a $100 million series C round for its selective ion channel modulators.
Elsewhere, Collegium Pharmaceuticals leverages its patented DETERx platform to provide extended release drug-delivery while deterring abuse and tampering and Cara Therapeutics is developing new chemical entities that target the body’s peripheral kappa opioid receptors to treat pruritus. And Protega Pharmaceuticals recently won approval for an abuse-deterrent opioid.
