Journavx: FDA approves opioid-free painkiller

The Food and Drug Administration approved Journavx (suzetrigine) 50-milligram oral tablets. It is a first-in-class non-opioid analgesic indicated to treat moderate to severe acute pain in adults.

According to the agency, Journavx acts on a pain signaling pathway involving sodium channels in the peripheral nervous system, before signals reach the brain.

In that regard, the FDA said Journavx is the first drug approved in this new class of drugs for the treatment of pain.

Similarly, officials detailed that the efficacy of Journavx was evaluated in two randomized, placebo-controlled active-drug trials on acute surgical pain, one after abdominoplasty and the other after bunionectomy.

In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were allowed to use ibuprofen as needed as a rescue analgesic. Both trials demonstrated a statistically significant reduction in pain with Journavx compared to placebo.

"The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions," the FDA highlighted.