Eight million Canadians a year take prescription pain medication — this could change their options
Health Canada has accepted for review a New Drug Submission (NDS) from Vertex Pharmaceuticals for suzetrigine, a treatment for moderate-to-severe acute pain in adults, the company announced Tuesday.
Vertex said suzetrigine is a selective NaV1.8 pain signal inhibitor, a new class of oral pain medicine that is neither an opioid nor a nonsteroidal anti-inflammatory drug.
If Health Canada approves it, suzetrigine would become the first new class of acute pain medicine available in Canada in more than twenty years.
Vertex said approximately 8m Canadian adults are prescribed pain medication each year to manage acute pain.
Michael Siauw, general manager at Vertex Pharmaceuticals Canada, said suzetrigine addresses "a significant unmet need" after more than two decades without a new class of acute pain medicine, expanding options for health care providers.
Vertex said it intends for the regulatory review to proceed as an aligned review alongside Canadian Health Technology Assessment (HTA) organisations: Canada's Drug Agency (CDA-AMC) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec.
Aligned reviews allow Health Canada and HTA bodies to share information, which Vertex said supports more timely patient access to new therapies.
NaV1.8, the channel that suzetrigine targets, is a voltage-gated sodium channel expressed selectively in peripheral pain-sensing neurons, known as nociceptors.
The company said NaV1.8 transmits pain signals and is not expressed in the human brain, and is not related to addiction.
Vertex added that suzetrigine has demonstrated a favourable benefit/risk profile across three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain.
The US Food and Drug Administration approved suzetrigine under the trade name JOURNAVX in January 2025 for the treatment of adults with moderate-to-severe acute pain, including postoperative pain.
The US application received breakthrough therapy, fast track, and priority review designations from the FDA.
Vertex describes itself as a global biotechnology company with approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain.
The company said it also has a clinical pipeline of investigational therapies in areas including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.
