Vertex to Present Phase 3 Data on Suzetrigine as a Selective Pain Signal Inhibitor at ASA Annual Meeting

Vertex Pharmaceuticals has announced that it will present its significant Phase 3 data on suzetrigine, an investigational oral NaV1.8 pain signal inhibitor, at the American Society of Anesthesiologists (ASA) annual meeting from October 18-22, 2024, in Philadelphia, Pennsylvania. The drug is being evaluated for its efficacy in treating moderate-to-severe acute pain.

Abstract A1187, titled "Randomized, Placebo-Controlled, Phase 3 Trials of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor for Treatment of Acute Pain After Abdominoplasty or Bunionectomy," will be presented on Sunday, October 20. This presentation is part of the "Best Abstract" session from 8:00-11:00 a.m. ET and will also be featured in an Education session on Monday, October 21, from 1:30-2:30 p.m. ET. Another piece of research, Abstract A2074, "A Phase 3, Single-Arm Study of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor For Treatment of Acute Pain From Surgical and Non-surgical Conditions," will be showcased in a poster session on Saturday, October 19, from 10:00-11:30 a.m. ET.

This marks the first occasion that Phase 3 data for suzetrigine will be publicly presented following the positive results announced in January 2024. The Phase 3 program comprised two randomized, double-blind, placebo-controlled trials—one focusing on post-abdominoplasty surgery pain and the other on post-bunionectomy surgery pain. Additionally, a single-arm safety and effectiveness study was included, enrolling patients with various surgical and non-surgical pain conditions. The results from these studies have demonstrated consistent efficacy and safety across different acute pain scenarios.

Carmen Bozic, M.D., Executive Vice President and Chief Medical Officer at Vertex, highlighted the significance of developing suzetrigine as the first non-opioid acute pain treatment in over two decades, aiming to revolutionize pain management. She expressed satisfaction with the selection of their Phase 3 data for the "Best Abstract" session at the ASA meeting, emphasizing the importance of sharing these findings with the medical community.

Todd Bertoch, M.D., an anesthesiologist and CEO of CenExel JBR Clinical Research, who will be the lead presenter for the suzetrigine Phase 3 data, noted the limited options available for pain treatment over the decades. He expressed optimism about the potential of suzetrigine to fill the gap between opioids and other therapies that either offer limited efficacy or poor tolerability.

Vertex is also progressing with the clinical development of suzetrigine for peripheral neuropathic pain (PNP). The company has initiated its Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy (DPN). Furthermore, Vertex is on track to release results from its Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR) by late 2024.

Acute pain, defined as pain lasting less than three months, affects over 80 million people annually in the U.S. who are prescribed medication for the condition. Given the limited treatment options, there is an unmet need for improved acute pain management to alleviate patient distress and reduce economic and societal burdens.

Suzetrigine is an investigational, highly selective NaV1.8 pain signal inhibitor. NaV1.8 is a voltage-gated sodium channel expressed in peripheral pain-sensing neurons, responsible for transmitting pain signals. Vertex's strategy involves selectively inhibiting NaV1.8 with small molecules to create a new class of pain signal inhibitors that provide effective pain relief without the limitations of current therapies, including the addictive potential of opioids. The drug has shown a favorable benefit/risk profile in multiple Phase 2 and Phase 3 studies for moderate-to-severe acute pain and has received FDA Fast Track and Breakthrough Therapy designations. Suzetrigine is currently under FDA priority review with a target action date of January 30, 2025, for the treatment of moderate-to-severe acute pain.

Vertex, founded in 1989 and headquartered in Boston, is a global biotechnology company focused on scientific innovation to develop transformative medicines for serious diseases. The company has approved treatments for cystic fibrosis, sickle cell disease, and beta thalassemia and continues to advance its clinical and research programs in these and other diseases.

These developments underscore Vertex's commitment to advancing pain management and addressing unmet medical needs through innovative therapeutic solutions.