Vertex Pharmaceuticals (Nasdaq: VRTX) announced that it will present Phase 3 data on suzetrigine, an investigational oral NaV1.8 pain signal inhibitor for moderate-to-severe acute pain, at the American Society of Anesthesiologists (ASA) annual meeting from October 18-22, 2024, in Philadelphia, PA. This marks the first public presentation of the Phase 3 data since positive trial results were announced in January 2024.
The data will be featured in two sessions:
- Abstract A1187: “Randomized, Placebo-Controlled, Phase 3 Trials of Suzetrigine for Acute Pain After Abdominoplasty or Bunionectomy” will be presented on October 20 during the “Best Abstract” session from 8:00-11:00 a.m. ET and on October 21 from 1:30-2:30 p.m. ET.
- Abstract A2074: “Phase 3, Single-Arm Study of Suzetrigine for Acute Pain From Surgical and Non-surgical Conditions” will be showcased as a poster on October 19 from 10:00-11:30 a.m. ET.
The Phase 3 program included two double-blind, placebo-controlled trials following abdominoplasty and bunionectomy, as well as a single-arm safety study across various pain conditions. Results demonstrated consistent efficacy and safety for suzetrigine in treating acute pain.
Dr. Carmen Bozic, Vertex’s Chief Medical Officer, emphasized the goal to introduce the first non-opioid acute pain treatment in over two decades, aiming to transform pain management. Lead presenter Dr. Todd Bertoch noted suzetrigine’s potential to fill the gap between opioids and other treatments with limited effectiveness.
Vertex is also advancing suzetrigine’s clinical development for peripheral neuropathic pain, with a Phase 3 program underway for diabetic peripheral neuropathy and Phase 2 results for lumbosacral radiculopathy expected in late 2024.
About Acute Pain
Acute pain is a disabling condition and is defined as pain lasting less than 3 months. It is estimated that over 80 million people are prescribed a medicine for acute pain every year in the U.S. Due to limited treatment options, there is an unmet need in acute pain management to improve the patient experience and reduce the economic and societal burden.
About Suzetrigine
Suzetrigine is an investigational oral, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids. Suzetrigine has demonstrated a favorable benefit/risk profile in multiple Phase 2 and Phase 3 studies in patients with moderate-to-severe acute pain and has been granted FDA Fast Track and Breakthrough Therapy designations in moderate-to-severe acute pain in the U.S. It is currently under priority review by the FDA for the treatment of moderate-to-severe acute pain with a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP) with the goal of pursuing a broad PNP label. Vertex recently initiated a Phase 3 pivotal program of suzetrigine in patients with painful diabetic peripheral neuropathy (DPN) and has completed enrollment in its Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR) — both are PNP conditions. Suzetrigine is investigational and has not been approved by any health authority.
