FDA Approves Suzetrigine For Treatment of Acute Pain

The FDA has approved suzetrigine (Journavx) for the treatment of moderate to severe acute pain in adult patients, Vertex announced in a release.¹ The decision makes the nonopioid, selective NaV1.8 pain signal inhibitor the first new class of medicine to treat acute pain in over 20 years.

The approval was based on data from a phase 3 program that included 2 randomized, double-blind, placebo-controlled trials, and a single arm safety and effectiveness study.² Data from the program showed treatment with suzetrigine resulted in statistically significant improvement in pain intensity. The therapy also demonstrated favorable safety and tolerability, with no serious adverse events occurring in any of the studies.

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“Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in a release.³ “A new nonopioid 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.”

Two of the phase 3 trials used to support the new drug application for suzetrigine evaluated the efficacy and safety of the therapy to treat acute pain following abdominoplasty (NCT05558410) and bunionectomy (NCT05553366). In total, the trials included more than 2000 adult patients who randomly received either an initial dose of suzetrigine 100 mg followed by 50 mg every 12 hours for 36 hours, hydrocodone bitartrate 5 mg and acetaminophen 325 mg every 6 hours for 42 hours, or placebo.

In both studies, treatment with suzetrigine demonstrated statistically significant improvements on the primary endpoint of the time-weighted sum of the pain intensity difference from 0 to 48 hours compared to placebo following abdominoplasty and bunionectomy. The therapy also had a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS). In a key secondary endpoint, suzetrigine had a more rapid onset to meaningful pain relief compared to placebo.

The single arm safety and effectiveness study (NCT05661734) evaluated the safety and efficacy of suzetrigine for acute pain. The study included 256 patients with a broad range of surgical and non-surgical moderate-to-severe acute pain conditions. Patients received an initial dose of 100 mg suzetrigine, followed by 50 mg every 12 hours for up to 14 days. The study found that the therapy was generally safe and well tolerated, with most adverse events being mild to moderate in severity. At the end of treatment, 83.2% of patients said the pain relief was good, very good, or excellent.

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” Jessica Oswald, MD, MPH, associate physician in Emergency Medicine and Pain Medicine in San Diego, said in a release.¹ “I believe Journavx could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”

READ MORE: Pain Management Resource Center

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References

1. Vertex Announces FDA Approval of JOURNAVX^™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain. News Release. Vertex. January 30, 2025. Accessed January 30, 2025. https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

2. Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. News Release. January 30, 2024. Accessed January 30, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-vx-548-phase-3-program

3. FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain. News Release. FDA. January 30, 2025. Accessed January 30, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain