Vertex non-opioid analgesic gets FDA approval

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The U.S. Food and Drug Administration (FDA) has approved Vertex’s Journavx, the first analgesic to be approved in a novel class of non-opioid pain medications indicated for moderate to severe acute pain relief.

In a statement, Vertex explained that Journavx is an oral highly selective NaV1.8 pain signal inhibitor that targets a pathway in the peripheral nervous system before pain signals reach the brain. Journavx is indicated for use by adults with moderate to severe acute pain, the firm said; moreover, it is a “well-tolerated medicine without evidence of addictive potential.”

Vertex’s application for Journavx received breakthrough therapy, fast track, and priority review designations by the FDA. 

Journavx was evaluated for safety and efficacy in two randomized, double-blind, placebo- and active-controlled trials with a study group of 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy; additional supportive safety data came from a single-arm, open-label study with 256 participants with “moderate to severe acute pain in a range of acute pain conditions,” the firm said.

Vertex noted that it is also evaluating Journavx for use in the treatment of peripheral neuropathic pain (PNP). The company has an ongoing phase III pivotal program for Journavx in patients with diabetic PNP; in addition, Vertex plans to move forward with evaluating the Journavx in patients with painful lumbosacral radiculopathy pending discussions with regulators.

The FDA noted in a statement that it encourages the development of non-opioid analgesics for the treatment of acute pain. The agency has issued draft guidance to assist with the development of non-opioid analgesics to manage acute pain. This guidance is part of the FDA Overdose Prevention Framework, which outlines the FDA’s approach to addressing the public health overdose crisis, and is designed to align with the U.S. Department of Health and Human Services' Overdose Prevention Strategy.

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