FDA Approves A First-in-Class Option for Moderate-to-Severe Acute Pain

Officials with Vertex Pharmaceuticals Incorporated announced that the FDA has approved suzetrigine (Journavx), a first-in-class, oral, nonopioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain.¹

The approval followed phase 3 data from 2 double-blind, placebo-controlled trials that evaluated the efficacy and safety of suzetrigine following abdominoplasty and bunionectomy surgery, as well as a single-arm study for acute pain in patients with a broad range of surgical and nonsurgical pain conditions.

“This is an incredible day for patients and physicians alike who now have an approved nonopioid 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, UC-San Diego and Vertex Acute Pain Steering Committee Member said in a press release about the approval.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.”

Acute pain is a serious and potentially disabling condition often caused by surgery, accident, or injury. More than 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid. Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually, so alternatives are key. Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the healthcare system and society.

Vertex is also evaluating suzetrigine in peripheral neuropathic pain. The company’s phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing.

Reference

1. Vertex Pharmaceuticals. Vertex announces FDA approval of Journavx (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain [press release]. Published January 30, 2025. Accessed January 31, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class