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

About this update from Vertex Pharmaceuticals Incorporated

– 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 e...

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