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FDA Approved Journavx, a Non-Opioid Drug for Pain Management

Knowledge

FDA Approved Journavx, a Non-Opioid Drug for Pain Management

February 20, 2025

Key Takeaways

  • U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults

  • This is the first new type of pain medication to be approved in more than 20 years

  • It is anticipated that payers will see an up-tick in the number of requests for this new drug. Journavx will likely follow the trajectory of other newer drugs and be fairly costly

On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type of pain medication to be approved in more than 20 years. The drug was approved for up to two weeks of pain management.

Suzetrigine is a sodium channel blocker that blocks a specific sodium channel called NaV1.8. The drug reduces pain by targeting pain-signaling pathways involving sodium channels in the peripheral nervous system before pain signals reach the brain.

With opioid addiction being a major public health concern affecting many New Yorkers—including injured workers—the NY State Legislation and the chair of the New York Workers’ Compensation Board implemented guidelines and safeguards throughout the years in an effort to mitigate opioid abuse.

In 2014, the chair adopted the Non-Acute Pain Medical Treatment Guidelines (NAP MTG). One of the vital purposes of implementing the guidelines was to create a comprehensive approach to the management of chronic pain and include best practice recommendations for the appropriate use of narcotics. The NAP MTG makes it clear that long-term opioid use is only recommended in limited circumstances and must involve constant clinical monitoring and re-evaluation. The NAP MTG also includes best practices for safely weaning injured workers from opioids and other narcotics.

Legislation was enacted in April 2017 requiring the NYS Workers’ Compensation Board to establish the New York Workers’ Compensation Drug Formulary. The formulary list designates drugs into different phases and therapies based upon a medication’s effectiveness and appropriateness for treatment of illness and injuries covered under workers’ compensation. Drugs listed on the formulary do not require pre-approval by the carrier or self-insured employer.

Although Journavx has presented a safer, non-opioid alternative to manage pain—which in turn will lower the chances of opioid abuse— there are still many unknowns surrounding the cost effects on insurance companies, specifically in workers’ compensation due to the nature of compensable injuries and surgeries. With the wholesale drug price not yet released, Journavx will likely follow the trajectory of other newer drugs and be fairly costly. Journavx’s list price—$15.50 per pill or $420 for a two-week course—is higher than what workers’ compensation typically pays for generic pain medication. “Since upwards of 80% of people who undergo surgery are prescribed opioids for pain, the new drug holds promise for keeping workers off the more dangerous drugs,” said Nikki Wilson, Omaha, Nebraska-based senior director of clinical pharmacy services at Enlyte LLC, who said comp payers are still navigating how the drug will impact the industry.

Because of the recent approval by the FDA, it is anticipated payers will see an up-tick in the number of requests for this new drug. Because Journavx is not listed on the formulary, all requests for the medication must be run through the PAR system first. We will be keeping a close eye on the prescription trends and how these requests are handled by the PAR system.

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