Vertex detailed Phase 3 data for its non-opioid treatment that could mark a drastic shift in pain management.
The company expanded on its interim readout on Sunday at the American Society of Anesthesiologists’ annual meeting. Back in January, Vertex said suzetrigine was statistically significant at improving pain symptoms compared to placebo following tummy tuck procedures and bunion removal surgery.
The full data show the drug was more pronounced in patients who had the tummy tuck procedure, with suzetrigine demonstrating a 48.4 mean improvement in pain compared to placebo as measured by a scale of post-operative pain symptoms after anesthesia wears off. Following bunion removal surgery, suzetrigine had a 29.3 mean difference from placebo on the same scale.
Lead investigator Todd Bertoch zeroed in on the number of adverse events that occurred post-treatment.
“This is the first study I’ve ever done where the investigational product had fewer adverse events than placebo,” he told Endpoints News. “I think that’s pretty remarkable.”
Half of the patients that were given suzetrigine had an adverse event after being treated after a tummy tuck, compared to 56.3% of patients given placebo and 60.7% given Vicodin. After bunion removal surgery, 31% of suzetrigine-treated patients had an adverse event versus 35.2% for placebo and 41.8% for Vicodin. There were no serious adverse events related to the drug, the new data showed.
Despite beating placebo and turning heads on safety, suzetrigine did not display a statistically significant improvement in pain reduction compared to Vicodin, a secondary endpoint in the trial. Bertoch, who has been a paid consultant for Vertex but does not work for the company, said the data still show a drug that could fill a gap in pain management.
“It looks like this drug is effective and you can put it in this place between where you need opioids and you have a safety profile that’s so much better,” he said.
The company also shared expanded single-arm data on Saturday. Those data similarly showed the drug was safe and had positive effectiveness ratings from patients. That trial included postoperative surgical patients and those who presented at a medical facility with moderate or severe acute pain that was new. There were no serious adverse events related to the drug, and 83.2% of trial participants said the effectiveness of suzetrigine at treating pain was good, very good, or excellent.
The three trials form the basis for Vertex’s approval application, which was accepted by the FDA in July with a decision set for the end of January 2025. In the meantime, studies expanding suzetrigine into neuropathic pain conditions are progressing. A Phase 2 study testing the treatment in patients with painful lumbosacral radiculopathy is still on track for a readout before the end of the year. Bertoch wouldn’t elaborate on how the data look, given that his clinical research organization is included in the study, but he expressed optimism.
“I don’t see a reason why that success should not translate into chronic pain,” he said.