Vertex reveals pivotal non-opioid pain data, indicating superior safety to placebo

Vertex Pharmaceuticals has presented the full data from its Phase 3 trials for suzetrigine, a non-opioid treatment for pain management, at the annual meeting of the American Society of Anesthesiologists. Initially, in January, Vertex announced that suzetrigine significantly improved pain symptoms compared to a placebo in patients undergoing tummy tuck procedures and bunion removal surgeries.

The detailed results reveal that suzetrigine had a more substantial effect on patients who underwent tummy tuck procedures. These patients showed a mean improvement of 48.4 in pain levels compared to the placebo, based on a post-operative pain symptom scale after the effects of anesthesia subsided. For bunion removal surgery, suzetrigine demonstrated a mean improvement of 29.3 over the placebo on the same scale.

Todd Bertoch, the lead investigator, highlighted the number of adverse events post-treatment. In a discussion with Endpoints News, Bertoch noted, "This is the first study I’ve ever done where the investigational product had fewer adverse events than placebo. I think that’s pretty remarkable."

Half of the tummy tuck patients treated with suzetrigine experienced an adverse event, compared to 56.3% of those on placebo and 60.7% on Vicodin. For bunion removal, 31% of suzetrigine-treated patients reported adverse events, versus 35.2% for placebo and 41.8% for Vicodin. Importantly, no serious adverse events tied to the drug were observed in the trials.

Despite outperforming the placebo and showing a strong safety profile, suzetrigine did not achieve a statistically significant reduction in pain compared to Vicodin, the trial's secondary endpoint. Bertoch, who has consulted for Vertex but is not an employee, commented that the data still indicates suzetrigine could play a pivotal role 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 remarked.

On the preceding Saturday, Vertex also presented expanded single-arm data. These findings similarly confirmed the drug's safety and positive effectiveness ratings from patients. This particular trial included postoperative surgical patients and individuals with moderate or severe acute pain who sought treatment at a medical facility. Consistently, no serious adverse events were associated with suzetrigine, and 83.2% of participants rated its effectiveness in managing pain as good, very good, or excellent.

These three trials collectively form the foundation for Vertex’s approval application, which the FDA accepted in July, with an expected decision by the end of January 2025. Concurrently, Vertex is expanding its studies to include neuropathic pain conditions. A Phase 2 study testing suzetrigine in patients with painful lumbosacral radiculopathy is anticipated to yield results before the year concludes. Although Bertoch's clinical research organization is involved in the study, making him cautious about specifics, he remains optimistic about its potential. "I don’t see a reason why that success should not translate into chronic pain," he stated.