FDA Approves Suzetrigine for Managing Moderate-to-Severe Acute Pain

On January 30, the FDA approved suzetrigine 50 milligram oral tablets, on-opioid analgesic, to treat moderate-to-severe acute pain in adults.

“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 an FDA press release. “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.”

The highly selective NaV1.8 pain signal inhibitor reduces pain by targeting sodium channels in the peripheral nervous system before the pain signals can reach the brain. Because the drug does not affect the brain, it eliminates the addictive potential that is often seen in opioid medications.

The approval of suzetrigine is based on data from two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, which both demonstrated significant superior pain reduction compared with placebo. Data from trials spanning 874 participants with moderate to severe acute pain after abdominoplasty and bunionectomy demonstrated a high safety profile. Furthermore, a single-arm, open-label study with 256 participants demonstrated safety in treating acute pain across a range of conditions.

Common adverse events included itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Suzetrigine may reduce the ability to become pregnant while using the treatment and may decrease the effectiveness of hormonal birth control medications containing progestins other than levonorgestrel or norethindrone.

References
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain. US Food and Drug Administration. January 30, 2025. Accessed January 31, 2025: https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain