FDA Approves First Non-Opioid Painkiller in Over Two Decades

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) approved suzetrigine, a groundbreaking non-opioid painkiller, on Thursday, marking the first new class of pain medication to gain approval in over two decades. The drug, marketed under the brand name Journavx, offers a safer alternative to opioids for managing acute pain.

Developed by Vertex Pharmaceuticals, suzetrigine is a 50-milligram pill taken every 12 hours after an initial 100-milligram dose. Unlike opioids, which act on the brain to dull pain and carry a high risk of addiction, suzetrigine works by blocking pain signals at their source, preventing them from reaching the brain.

“A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research. “This action underscores FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

Approximately 80 million Americans are prescribed medications annually for moderate to severe pain, with half of those prescriptions being for opioids. Suzetrigine’s approval comes as the U.S. continues to grapple with an opioid crisis that has led to widespread addiction and overdose deaths.

The drug’s development was inspired by a family of fire walkers in Pakistan who lack a gene that allows pain signals to fire in their skin. Researchers discovered that these individuals could walk on hot coals without feeling pain, leading to the identification of a sodium channel responsible for pain signaling. Suzetrigine works by selectively blocking this channel.

“This drug is interrupting that path, so even though the tissue injury exists, the brain doesn’t know,” explained Dr. Sergio Bergese, an anesthesiologist at Stony Brook University’s Renaissance School of Medicine. “Crucially, suzetrigine creates no euphoria or high, so there’s no potential for addiction.”

In clinical trials involving nearly 600 participants, suzetrigine reduced post-surgical pain by about 50% compared to a placebo. However, it showed limited effectiveness in treating chronic pain, such as sciatica, where its performance was similar to a placebo. Vertex is continuing to test the drug for chronic pain conditions, including diabetic neuropathy.

Despite its limitations, suzetrigine represents a significant step forward in pain management. “It provides proof of concept that a sodium-channel blocker can reduce pain in humans,” said Dr. Stephen Waxman, director of the Center for Neuroscience and Regeneration Research at Yale School of Medicine. “This opens the door to a second generation of even more effective medications.”

The drug’s approval is expected to have a major impact on the pharmaceutical industry, with analysts predicting annual sales could exceed $1 billion. However, doctors caution that suzetrigine may not be suitable for all patients or types of pain.