The U.S. Food and Drug Administration (FDA) has approved Suzetrigine, a new non-opioid pain relief drug sold under the brand name Journavx, to treat moderate to severe acute pain in adults.

Journavx from Vertex Pharmaceuticals marks the first new class of pain reliever to receive FDA approval in over two decades. It will be sold as 50-milligram prescription pills that work by blocking pain signals at their source by targeting sodium channels in the nervous system and stopping pain before it reaches the brain.

"Today's approval is an important public health milestone in acute pain management. 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," Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research said in a news release.

Non-opioid pain relief is a crucial step forward in addressing the ongoing opioid crisis. With over 80 million Americans requiring pain relief, around half are prescribed opioids. However, nearly 10% of those initially prescribed opioids end up using them long-term, and about 85,000 develop opioid use disorder each year. Non-opioid alternatives offer a safer option for pain management, reducing the risk of dependency.

According to the manufacturer, Journavx is a well-tolerated, effective pain reliever with no signs of addictive potential, designed for all types of moderate to severe acute pain.

The efficacy of the drug was tested in two clinical trials involving surgical pain, one after tummy tuck surgery (abdominoplasty) and the other after bunion surgery. Participants were randomly given either Journavx or a placebo. If pain control was not enough, they could also take ibuprofen for extra relief. Both trials showed that Journavx worked significantly better than a placebo in reducing pain.

The safety of Journavx was evaluated based on data from two main trials with 874 participants who had moderate to severe acute pain after a tummy tuck or bunion surgery, along with additional data from a smaller study with 256 participants in various acute pain conditions.

The most common side effects reported were itching, muscle spasms, elevated creatine phosphokinase levels, and rash. Journavx should not be taken with strong CYP3A inhibitors, and patients should avoid grapefruit or grapefruit-containing foods and drinks while using it. The drug will be priced at $15.50 per 50mg pill.

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