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If approved, the drug would be the first in a new class of medications to treat acute pain in over 20 years.
The FDA has accepted a new drug application for suzetrigine (previously VX-548; Vertex Pharmaceuticals Incorporated), an investigational, selective NaV1.8 pain signal inhibitor, to treat moderate-to-severe acute pain. If approved, the drug would be the first in a new class of medications to treat acute pain in over 20 years.1
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"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either under-treated, dealing with negative side effects of currently available therapies, or foregoing pain medications altogether for fear of becoming dependent on opioids,” Scott Weiner, MD, MPH, associate professor of Emergency Medicine at Harvard Medical School, said in a press release. “Prescribers and patients deserve new options."1
Pain is categorized as the activation of nociceptors, which are nerve endings that respond to harmful stimuli, and pain can be either acute or chronic. There are 2 nerve fibers where pain signals are transmitted: myelinate A-delta fibers and unmyelinated C fibers. Myelinate A-delta signals sharp and immediate pain and unmyelinated C signals dull aching pain. Opioids were once considered the gold standard for managing acute pain because they support binding to the central nervous system and produce analgesia affects.2
However, opioids have been associated with potential addiction, tolerance, and overdose, so the drugs have to be carefully monitored. Clinical practice has moved away from the use of opioids for acute pain. According to the CDC, nonopioid therapies have shown effectiveness similar to opioids for many common types of acute pain. The agency recommends maximizing the use of nonpharmacologic and nonopioid pharmacological therapies, and opioids for acute pain should have benefits that outweigh the risk for the patient. Alternative treatments can include physical activity, transcutaneous electric nerve stimulation, and nonopioid medications, which include nonsteroidal anti-inflammatory drugs, acetaminophen, steroids, antidepressants, anticonvulsants, and topical medications.3,4
In a study of suzetrigine, investigators found that, at the highest dose, the drug reduced acute pain over a 48-hour period after abdominoplasty or bunionectomy with mild-to-moderate adverse events. The trial was conducted as 2 phase 2, randomized, double-blind, placebo-controlled studies. Patients included were aged 18 to 75 years with a pain score of at least 4 on the Numeric Pain Rating Scale. Pain was also rated as moderate or severe on the Verbal Categorical Rating Scale within 4 hours after completion of the surgery and general anesthesia for those who underwent abdominoplasty and within 9 hours after removal of popliteal sciatic nerve block on postoperative day 1 in the bunionectomy trial.5
In the abdominoplasty trial, 303 individuals were included, with 81.5% completing the treatment period. For the bunionectomy trial, 274 individuals were included with 90.1% completing the treatment. The least-squares mean difference for the high-dose group and placebo group was 37.8 for those in the abdominoplasty trial and 36.8 in the bunionectomy trial. For both studies, individuals who received the lower doses had similar results to the placebo.5
Headache and constipation were the most common adverse events reported with suzetrigine, according to the study authors.5
The FDA has granted the drug priority review, assigning a Prescription Drug User Fee Act target action date of January 30, 2025. Further, it was previously granted FDA fast track and breakthrough therapy designations.1
