Health Canada Accepts Vertex's Suzetrigine New Drug Submission for Acute Pain

Health Canada has accepted for review a New Drug Submission (NDS) for suzetrigine for the treatment of moderate-to-severe acute pain in adults, Vertex Pharmaceuticals announced. Suzetrigine is a selective NaV1.8 pain signal inhibitor that represents a new class of oral pain medicine; it is not an opioid or a nonsteroidal anti-inflammatory drug (NSAID).

If approved by Health Canada, suzetrigine has the potential to be the first new class of medicine in Canada to treat acute pain in over twenty years. Each year, approximately 8 million Canadian adults are prescribed pain medication to manage their acute pain. Vertex intends for the regulatory review of suzetrigine to be part of an aligned review with Canadian Health Technology Assessment organizations: Canada's Drug Agency (CDA-AMC) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec. "Today's acceptance of our NDS for suzetrigine represents an important step in our mission to transform pain management in Canada," said the General Manager at Vertex Pharmaceuticals (Canada) Incorporated.

Suzetrigine was approved by the U.S. Food and Drug Administration under the trade name JOURNAVX in January 2025. The U.S. application received breakthrough therapy, fast track, and priority review designations. The FDA approved twice-daily JOURNAVX for the treatment of adults with moderate-to-severe acute pain, including postoperative pain.

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). NaV1.8 is not expressed in the human brain and is not related to addiction. NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain.

Voltage-gated sodium (Nav) channels, which govern the initiation and propagation of action potentials, have emerged as promising targets for mechanism-based analgesic development. The Nav1.7-Nav1.9 subtypes have attracted substantial interest owing to their enrichment in the peripheral nervous system and their central roles in nociception, offering the potential for non-addictive, subtype-selective pain modulation. The FDA approval of suzetrigine, a first-in-class and highly selective Nav1.8 inhibitor, marks a major milestone that validates peripheral Nav channels as clinically actionable targets for analgesia. Current analgesic strategies rely heavily on opioid medications and NSAIDs; however, concerns regarding addiction, tolerance, and dose-limiting adverse effects highlight the urgent need for safer and more effective therapeutics.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain. Vertex was founded in 1989 and has its global headquarters in Boston.