Vertex Announces New Drug Submission for Suzetrigine Has Been Accepted for Review by Health Canada for the Treatment of Moderate-to-Severe Acute Pain in Adults
– Suzetrigine, a selective pain signal inhibitor, has the potential to treat millions of Canadians who suffer from moderate-to-severe acute pain each year –
TORONTO, May 21, 2026 /CNW/ - Vertex Pharmaceuticals (NASDAQ:VRTX) today announced that Health Canada has accepted for review a New Drug Submission (NDS) for suzetrigine for the treatment of moderate-to-severe acute pain in adults. 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.
"Today's acceptance of our NDS for suzetrigine represents an important step in our mission to transform pain management in Canada," said Michael Siauw, General Manager at Vertex Pharmaceuticals (Canada) Incorporated. "Canadians experiencing acute pain deserve access to innovative treatment options. After more than two decades without a new class of acute pain medicine, suzetrigine has the potential to address this significant unmet need and expand the options available to health care providers."
Vertex intends for the regulatory review of suzetrigine to be part of an aligned review with Canadian Health Technology Assessment (HTA) organizations: Canada's Drug Agency (CDA-AMC) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec. Aligned reviews provide an opportunity for information sharing between Health Canada and HTA bodies, leading to greater coordination to support Canadians' timely access to effective new therapies.
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.
About Suzetrigine
Suzetrigine (JOURNAVX) is an investigational, oral, selective NaV1.8 pain signal inhibitor. 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.
The U.S. Food and Drug Administration approved twice-daily JOURNAVX for the treatment of adults with moderate-to-severe acute pain, including postoperative pain.
About Vertex
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, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, 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.
Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com/en-ca.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Michael Siauw in this press release, statements regarding the expected benefits of suzetrigine, including its potential to be the first new class of medicine in Canada to treat acute pain in over twenty years, and statements regarding expectations for the aligned review with the HTA, CDA-AMC and the INESSS. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that regulatory authorities in Canada may not approve suzetrigine on a timely basis or at all, and other risks listed under the heading "Risk Factors" in Vertex's annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com and www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
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