The U.S. Food and Drug Administration (FDA) recently approved Journavx™ (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic developed to treat moderate to severe acute pain in adults. It works by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. The drug is manufactured by Vertex Pharmaceuticals Inc, which has its North American headquarters in Boston, Massachusetts.

 

“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. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

 

Read the full FDA release for more information on suzetrigine, including relevant clinical trial results, common adverse reactions, and further background on its approval. You can also learn more about FDA initiatives designed to foster the development of more non-opioid analgesics for the treatment of pain.

 

Individuals considering new medications are advised to discuss efficacy, safety, and any other concerns with their primary care doctor. People with bleeding disorders are also strongly encouraged to consult with the comprehensive care team at their hemophilia treatment center.

 

Source: FDA news release dated January 30, 2025, and USA Today, January 31, 2025

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