The U.S. Food and Drug Administration (FDA) has approved suzetrigine, the first drug in a new family of non-opioid painkillers to treat moderate-to-severe acute pain.

Suzetrigine, to be sold under the brand name Journavx, is the first new type of pain medicine approved by the FDA in more than two decades. It works by stopping nerve cells from sending pain signals to the brain.

Unlike oxycodone and other opioids, which can become addictive because they impact reward centers in the brain, suzetrigine is thought to be nonaddictive because it targets nerve cells outside the brain.

“A novel, effective pain medication that has no potential to induce overdose or addiction is a game-changer,” says Keith Humphreys, PhD, a psychiatry professor at Stanford University in California.

The new drug is only approved for acute pain, meaning pain typically lasting less than three months. It’s not cleared for chronic pain.

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, MD, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”

Suzetrigine Could Replace Opioids in Some Cases

In two late-stage clinical trials of more than 2,000 adults who had moderate-to-severe pain after surgery, suzetrigine eased pain significantly more than a placebo without causing any serious side effects, according to findings presented at the American Society of Anesthesiologists meeting last year. But suzetrigine didn’t relieve pain as much as the opioid hydrocodone.Another mid-stage clinical trial of about 200 patients with a type of nerve compression that causes sciatica also found suzetrigine significantly reduced pain. But people in this study experienced similar improvements whether they took suzetrigine or a placebo (dummy pill).

“The results are indeed mixed, but even if suzetrigine replaces opioids as a first-line pain therapy option for only some procedures, that would reduce the healthcare system’s overall risk of inducing opioid use disorder in patients,” Dr. Humphreys says.