FDA approves non-opioid pain medication
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The Food and Drug Administration on Tuesday approved Journavx, the first drug in a new class of non-opioid pain medications, for treating moderate to severe acute pain in adults.
The oral tablet targets sodium channels in the peripheral nervous system, reducing pain signals before they reach the brain. This mechanism differs from traditional pain relievers, including opioids.
“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,” said Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research.
The FDA has prioritized the development of non-opioid pain treatments, particularly amid the ongoing opioid crisis.
The effectiveness of Journavx was demonstrated in two clinical trials involving patients with acute surgical pain. The trials, which included a placebo and an active comparator, showed Journavx significantly reduced pain compared to the placebo. Participants could also use ibuprofen as needed for additional pain relief.
Common side effects associated with Journavx include itching, muscle spasms, elevated creatine phosphokinase levels, and rash. The drug should not be taken with strong CYP3A inhibitors, and patients should avoid grapefruit and grapefruit juice while taking it.
The FDA granted Journavx breakthrough therapy, fast track, and priority review designations. Vertex Pharmaceuticals Incorporated is the drug’s manufacturer.