Vertex Pharmaceuticals' suzetrigine, a novel non-opioid analgesic, is currently under review by the FDA for the treatment of moderate-to-severe acute pain. The drug, which targets the NaV1.8 receptor to prevent pain signals from reaching the brain, has shown promise in clinical trials as an alternative to opioids, potentially reducing the risk of opioid use disorder.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025, for suzetrigine. If approved, it would offer a new mechanism of action for pain relief, addressing a significant unmet need for patients who cannot tolerate or are at high risk from opioids and NSAIDs.
Clinical Trial Data
ICER assessed data from two Phase 3 randomized trials comparing suzetrigine to placebo and hydrocodone/acetaminophen in patients undergoing bunionectomy and abdominoplasty. The trials included 873 patients receiving suzetrigine, 879 receiving hydrocodone/acetaminophen, and 439 receiving placebo.
Results indicated that suzetrigine led to greater and faster pain reductions compared to placebo. While suzetrigine's efficacy was similar to hydrocodone/acetaminophen for abdominoplasty, it exhibited a slower onset of pain relief for bunionectomy. Adverse effects were comparable to placebo, with nausea being less frequent than with hydrocodone/acetaminophen.
Cost-Effectiveness and Safety Considerations
ICER's analysis suggests that suzetrigine could result in lifetime savings of $200 compared to opioids, primarily due to the reduced risk of opioid use disorder. This conclusion is based on a placeholder price of $420 for a one-week course of suzetrigine.
"We thought [opioid use disorder] was the appropriate way to look at the cost-effectiveness of this product," said David M. Rind, M.D., chief medical officer at ICER. "We focused heavily on this report on cost-effectiveness compared with opioids, assuming that there’s some risk to opioid use disorder, addiction, even from short courses."
However, Rind also noted uncertainties regarding the long-term safety of suzetrigine, emphasizing the need for post-market surveillance to identify rare or low-level risks associated with its novel mechanism of action.
Market Positioning and Future Studies
Vertex Pharmaceuticals is positioning suzetrigine as an opioid alternative, targeting hospitals, surgical specialties, anesthesiologists, pain specialists, and emergency departments. A company survey revealed that 78% of healthcare providers are concerned about opioid addiction risks among acute pain patients, and 88% of patients prefer non-opioid pain management.
Beyond acute pain, Vertex is also investigating suzetrigine in Phase 3 trials for diabetic peripheral neuropathy and Phase 2 trials for lumbosacral radiculopathy, potentially expanding its therapeutic applications.
