FDA Approves New Medication for Acute Pain

The U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceutical’s Journavx (suzetrigine), a new type of prescription pain medication for adults to treat moderate to severe acute pain. This first class non-opioid pain medication, which doesn’t have addictive properties (unlike opioids often used for this type of pain) is the first to be approved by FDA in more than 20 years. Journavx works by inhibiting the NaV1.8 pain signal in the peripheral nervous system, a channel that is not expressed in the brain or anywhere else in the central nervous system, which is why it does not have addictive properties like opioids. 

Approval was based two clinical trials that found Journavx to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug. One trial that tested the medicine in adults between ages 18 and 80 found it reduced moderate to severe acute pain for adults from baseline by about 50 percent in 48 hours. The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group. In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective, with more than 80 percent of patients rating Journavx as a good, very good or excellent pain medication when investigating multiple acute pain types.

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

The drug cannot be used with certain other drugs that strongly inhibit a certain enzyme in the liver, so some people may not be able to take Journavx, depending on what other medications they are taking. Grapefruit should also be avoided while taking Journavx.