For the first time in several decades, physicians have a new oral non-opioid drug to combat pain. It’s a vital tool, considering that more than 125 million opioid prescriptions were written in the U.S. in 2023, according to the Centers for Disease Control and Prevention. Even more alarming, opioids, with their addictive nature, are responsible for 80,000 U.S. overdose deaths a year, reports the National Institute on Drug Abuse.
Eduardo Icaza, M.D., a board-certified anesthesiologist and pain management specialist at Baptist Health Miami Neuroscience Institute.
The new medication, called VX-548 or suzetrigine, just received approval from the U.S. Food and Drug Administration (FDA). It’s welcome news for the spine experts at Baptist Health Miami Neuroscience Institute.
“The reality is that for patients suffering from acute pain episodes or living with chronic pain, our medication toolbox has been pretty stagnant,” said Eduardo Icaza, M.D., a comprehensive and interventional pain management specialist at the Institute. “It has been frustrating for us and frustrating for patients because we want to provide pain relief, but our current medication regimens, such as opioids or non-steroid anti-inflammatory drugs (NSAIDs) have well-known side effects.”
Dr. Icaza briefed other physicians on the new medication at the 2025 Baptist Health Spine Symposium, a forum held in January for physicians and other providers to learn from experts in multiple subspecialties about the latest advances for patients with spine pain.
Known as a sodium channel inhibitor, suzetrigine works by reducing the activation of pain-signaling neurons, preventing or lowering the transmission of pain signals to the brain. “The more active and open the channel is, the more likely that it is firing pain signals,” Dr. Icaza said.
Sodium channels are present throughout the body, including in the brain, the heart and the peripheral nervous system. While sodium channel blocker medications are not new (think local anesthetics such as Novocain injections for dental work or lidocaine prior to suturing a laceration), the drawback to their use has been that if put in pill form, they could potentially cause debilitating side effects in the brain and heart.
The new oral drug targets a specific sodium channel found only in the peripheral nervous system. Previously, the FDA granted suzetrigine its breakthrough therapy designation to treat pain from diabetic peripheral neuropathy. The designation is designed to help speed the development of new drugs for serious or life-threatening conditions.
“In studies that looked at post-operative pain, nearly half of all patients reported a high reduction in pain with the new drug, and in the pain world we consider even a 30 percent reduction in pain to be significant,” Dr. Icaza said. “The studies were fairly small and there is still more work to be done to determine who might be the best responders to the medication. But we are hopeful that this will be efficacious and lead to the development of more targeted medications.” Common side effects include headaches and constipation in 10-15 percent of patients.
It could take several months for suzetrigine to become widely available. If you currently take opioids for pain, ask your physician about non-opioid options.
