FDA approves Vertex’s first-in-class non-opioid analgesic for acute pain

Investing.com -- Today, the U.S. Food and Drug Administration (FDA) gave its approval to Vertex Pharmaceuticals’ (NASDAQ: NASDAQ:VRTX) Journavx (suzetrigine) 50 milligram oral tablets. This new drug is a non-opioid analgesic, the first of its kind, designed to treat moderate to severe acute pain in adults. Journavx works by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, which intercepts pain signals before they reach the brain.

This approval marks the first time a drug from this new class of pain management medicines has been approved. The relief of pain is a significant therapeutic goal, especially acute pain which is short-term and typically a response to tissue injury, like trauma or surgery. Acute pain is often managed with analgesics that may or may not contain opioids.

The FDA has shown consistent support for the development of non-opioid pain treatments. As part of the FDA’s Overdose Prevention Framework, the agency has issued draft guidance to encourage the development of non-opioid analgesics for acute pain. Additionally, the FDA has awarded cooperative grants to support the development and dissemination of clinical practice guidelines for managing acute pain conditions.

Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research, stated that the approval of Journavx is an important public health milestone in acute pain management. She noted that a new non-opioid therapeutic class for acute pain can help reduce certain risks associated with using opioids for pain management and provides patients with an additional treatment option. She also highlighted the FDA’s commitment to approving safe and effective alternatives to opioids for pain management.

The effectiveness of Journavx was assessed in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain. These trials were conducted following abdominoplasty and bunionectomy procedures. All participants in the trials were allowed to use ibuprofen as a "rescue" pain medication if the pain was not adequately controlled. Both trials demonstrated a significant superior reduction in pain with Journavx compared to a placebo.

The safety profile of Journavx is primarily based on data from these trials, involving 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy. Additional supportive safety data was derived from one single-arm, open-label study involving 256 participants with moderate to severe acute pain in a variety of acute pain conditions.

Common adverse reactions in study participants who received Journavx included itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx should not be used together with strong CYP3A inhibitors, and patients are advised to avoid food or drink containing grapefruit when taking the medication.

The FDA granted Journavx Breakthrough Therapy, Fast Track, and Priority Review designations. The approval of Journavx was granted to Vertex Pharmaceuticals Incorporated.

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