The U.S. Food and Drug Administration (FDA) has approved Journavx, a new non-opioid pain medication, marking the first approval of its kind in over 25 years. Developed by Vertex Pharmaceuticals, Journavx, also known as suzetrigine, is designed to treat moderate to severe acute pain, often experienced after surgeries or injuries.
Journavx works by blocking sodium channels in the peripheral nervous system, preventing pain signals from reaching the brain. This mechanism differs from opioids, which dull pain by affecting the brain directly. The drug’s approval is seen as a significant step in providing alternatives to opioids, which carry risks of addiction and overdose. According to the FDA, this new class of pain management medicine offers a safer option for patients.
“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., 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.
Clinical trials involving nearly 900 participants demonstrated that Journavx effectively reduced pain following surgeries like abdominoplasty and bunionectomy. While it did not outperform traditional opioid-acetaminophen combinations, it provided significant pain relief compared to a placebo. Common side effects include nausea, constipation, and rash, but the drug does not pose the addiction risks associated with opioids.
Vertex Pharmaceuticals began researching suzetrigine in the early 2000s, inspired by a family of fire walkers in Pakistan with a genetic mutation that prevents pain signaling. Despite some challenges in development, the approval of Journavx is expected to pave the way for future advancements in pain management.
The drug will be available at a list price of $15.50 per pill, significantly higher than generic opioids. Vertex plans to continue exploring suzetrigine’s potential for treating chronic pain despite mixed results in earlier trials.
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