FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic

In July, the U.S. Food & Drug Administration (FDA) accepted a new drug application for suzetrigine, an oral, non-opioid analgesic. Suzetrigine, formerly known as VX-548, has been granted priority review and given a U.S. Prescription Drug User Fee Act target action date of Jan. 30, 2025. The agent has also been given FDA fast-track and breakthrough-therapy designations for the treatment of moderate to severe acute pain.¹

Background

Suzetrigine selectively inhibits NaV1.8, a voltage-gated sodium channel. In clinical trials that included more than 2,000 patients who were 18–80 years old, this agent was well tolerated and effective for the treatment of moderate to severe acute pain.²

In a phase 2 clinical trial of patients with painful diabetic neuropathy, suzetrigine led to meaningful pain relief in post-surgical pain intensity (P values not reported). Also, throughout three phase 3 and two phase 2 clinical trials, suzetrigine demonstrated a favorable benefit/risk profile.²

In a phase 3 clinical trial of patients post-abdominoplasty, at least 5% of patients experienced adverse events, including nausea (19%), constipation (10.5%), headache (4.2%), dizziness (4–5.4%) and hypotension (2.5%). These values were equal to or lower than the control groups taking acetaminophen/hydrocodone or placebo.¹

In another phase 3 clinical trial of patients post-bunionectomy, adverse events were experienced by at least 5% of patients, including nausea (8.2%), headache (4.9%), constipation (3.5%) and dizziness (3.5%)—all lower values than the control or placebo groups. No serious adverse events were reported.²

Additional research plans for suzetrigine include a broader indications for peripheral neuropathic pain, including diabetic peripheral neuropathy and painful lumbosacral radiculopathy.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Vertex announces FDA acceptance of new drug application for suzetrigine for the treatment of moderate-to-severe acute pain [news release]. Vertex Pharmaceuticals Inc. 2024 Jul 30.
2. Vertex announces positive results from the VX-548 phase 3 program for the treatment of moderate-to-severe acute pain [news release]. Vertex Pharmaceuticals Inc. 2024 Jan 30.