FDA Approves Suzetrigine, a Non-Opioid Option, for Treatment of Acute Pain

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced the approval of suzetrigine (Journavx), a non-opioid pain signal inhibitor, for treatment of adults with moderate to severe acute pain.¹

Announced on January 30, 2025, the approval of suzetrigine marks the first new class of medication in more than 20 years for patients suffering from acute pain.²

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA's Center for Drug Evaluation and Research.¹ “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."

Suzetrigine, previously referred to as VX-548, is an oral, selective inhibitor of NaV1.8, a voltage-gated sodium channel specifically expressed in peripheral pain-sensing neurons, or nociceptors. These pain-sensing neurons maintain a key role in transmitting pain signals through action potentials.

Through its selective inhibition of NaV1.8, the medication is designed to provide substantial relief from pain without any of the limitations observed with any existing treatments. Such limitations might include the risks of addiction connected to opioid use.

Prior to this approval, the investigational drug demonstrated a favorable safety and efficacy profile in those with moderate-to-severe acute pain evaluated in multiple phase 2 and 3 clinical studies. Suzetrigine also has promising results and was well-tolerated in a phase 2 clinical trial on patients with a chronic form of neuropathic pain known as diabetic peripheral neuropathy.²

According to the FDA's announcement of the January 30, 2025 approval, the efficacy of suzetrigine was evaluated in 2 randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, with 1 trial conducted among patients following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. In both trials, suzetrigine demonstrated a statistically significant superior reduction in pain compared to placebo.¹

“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," Corrigan-Curay added.

References

1. ^{Office of the Commissioner. FDA approves novel non-opioid treatment for moderate to severe acute pain. U.S. Food and Drug Administration. 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.}
2. ^{Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain. Vertex Pharmaceuticals Incorporated. July 30, 2024. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-acceptance-new-drug-application-suzetrigine. Date accessed: January 28, 2025.}