The U.S. FDA has approved Vertex’s Journavx, an oral, non-opioid pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain, marking the first new class of pain medicine approved in the U.S. in more than 20 years.
The twice-daily 50 milligram oral tablets reduce pain by targeting NaV1.8, a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Importantly, because Journavx blocks pain signals only found in the periphery, not in the brain, it provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.
The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for ‘rescue’ pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.
A phase 3 pivotal program for Journavx in patients with painful diabetic peripheral neuropathy is ongoing, and Vertex plans to advance its pivotal program evaluating the drug in patients with painful lumbosacral radiculopathy pending discussions with regulators.
Vertex has established a wholesale acquisition cost for Journavx in the U.S. of $15.50 per 50 mg pill.