Buccolam® Arrives in Canada, Offering New Hope for Pediatric Seizure Treatment

MONTREAL, QC – February 27, 2026 – A significant new treatment option for managing pediatric epilepsy emergencies is now available across Canada. Pendopharm, the specialty pharmaceutical division of Pharmascience Inc., today announced the commercial launch of Buccolam®, a medication designed for the emergency treatment of prolonged, acute, convulsive seizures in children and adolescents.

The launch marks a critical milestone for Canadian patients and caregivers, providing a rapid, non-invasive rescue medication for a frightening and dangerous medical event. It is the result of a strategic partnership between Montreal-based Pendopharm and Neuraxpharm Group, a leading European pharmaceutical company specializing in central nervous system (CNS) disorders.

"We are proud to introduce Buccolam® to patients in Canada," said Jad Isber, Vice President & General Manager of Pendopharm, in a statement. "This launch underscores Pendopharm's continued commitment to bringing medicines to Canadian patients."

A New Lifeline for Families and Caregivers

For families managing pediatric epilepsy, the threat of a prolonged seizure—one lasting more than five minutes—is a constant source of anxiety. These events, known as status epilepticus, can lead to serious health complications and often require emergency room visits. Buccolam® (midazolam oromucosal solution) is specifically designed to address this critical moment of need.

Indicated for children and adolescents from three months to under 18 years of age, Buccolam® is administered into the buccal cavity, the space between the gum and the cheek. This route allows the medication to be absorbed quickly into the bloodstream, helping to stop a seizure rapidly. Its key advantage lies in its ease of use, especially in a high-stress emergency.

The medication comes in pre-filled, single-use oral syringes that are color-coded by age-appropriate dosage, minimizing the risk of error. This design allows parents, school staff, or other caregivers to administer the treatment quickly and effectively without the need for specialized medical training, a stark contrast to other emergency options.

Previously, the standard of care for out-of-hospital rescue treatment often involved rectally administered diazepam, a method that can be socially challenging, stigmatizing, and difficult to administer, particularly in public. The other alternative, intravenous medication, requires a hospital setting and a trained professional to gain IV access, which can be difficult and time-consuming in a convulsing child. Buccolam® bypasses these challenges entirely.

"As a physician, I'm excited to hear that Buccolam®, will be available for patients in Canada," commented a specialist from the Cumming School of Medicine at the University of Calgary, reflecting the anticipation within the medical community for more accessible treatment options.

The Clinical Advantage: How Buccolam® Works

Health Canada granted authorization for Buccolam® on July 22, 2025, following a thorough review of its clinical profile. The active ingredient, midazolam, is a well-established benzodiazepine that acts as a potent anti-convulsant. It works by enhancing the effects of GABA, the brain's primary inhibitory neurotransmitter, which helps to calm the excessive electrical activity that causes seizures.

Clinical studies have demonstrated the efficacy and speed of the oromucosal formulation. Data from multiple trials show that buccal midazolam is effective in stopping seizures within 10 minutes in approximately 65% to 78% of children. Its effectiveness is considered comparable, and in some studies superior, to rectal diazepam, and similar to intravenous diazepam administered in a hospital setting.

The ability to intervene quickly is critical. Stopping a seizure promptly can reduce the risk of neurological damage and decrease the likelihood of requiring hospitalization. By providing a reliable tool for early intervention, Buccolam® has the potential to significantly improve patient outcomes and reduce the burden on the healthcare system.

While generally well-tolerated, the medication carries risks common to benzodiazepines, such as respiratory depression. Health Canada has reviewed and approved a comprehensive Risk Management Plan to ensure it is used safely and appropriately.

A Strategic Partnership to Bridge Continents

The introduction of Buccolam® to the Canadian market is a direct result of the collaboration between Pendopharm and Neuraxpharm. This partnership exemplifies a growing trend in the pharmaceutical industry where specialized companies leverage each other's strengths to bring innovative medicines to new markets.

Pendopharm, with its deep expertise in the Canadian pharmaceutical landscape and established focus on neurology, provides the ideal platform for commercializing a CNS product. For Neuraxpharm, a German company with a strong presence across Europe and a growing global footprint, the partnership represents a key step in its international expansion strategy.

"Expanding access to medicines outside Europe is a key priority for Neuraxpharm," said Dr. Maximilian von Wülfing, Chief Operating Officer of Neuraxpharm. "Partnering with Pendopharm to launch Buccolam® in Canada not only strengthens our international presence but importantly, helps ensure more patients and healthcare professionals have reliable access to this treatment."

This collaboration allows a proven European therapy to reach Canadian patients, addressing an unmet medical need while bolstering the portfolios of both companies.

From Approval to Access: The Canadian Journey

While the commercial launch is a crucial step, the journey to broad patient access in Canada is a multi-stage process. Following Health Canada's regulatory approval, the next phase involves securing reimbursement from provincial and territorial public drug plans.

New drugs are typically evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH) and Quebec’s l'Institut national d'excellence en santé et en services sociaux (INESSS). These bodies assess the clinical effectiveness and cost-effectiveness of a drug before making reimbursement recommendations to the provinces.

Following a positive recommendation, the pan-Canadian Pharmaceutical Alliance (pCPA) negotiates pricing with the manufacturer on behalf of the public drug plans. Only after these negotiations are complete can individual provinces decide to list the drug on their public formularies.

The need is pressing. Over 100,000 Canadians live with epilepsy that is not controlled by existing treatments, and the community has recently grappled with shortages of other critical epilepsy medications. Patient advocacy groups consistently call for timely and equitable access to new therapies that can improve quality of life and reduce the strain on patients and their families.

The unique advantages of Buccolam®—its ease of administration, rapid action, and potential to reduce emergency room visits—will form a strong case for its inclusion on public formularies. The successful navigation of this reimbursement pathway will be the final, critical step in ensuring this innovative treatment reaches all the Canadian children who stand to benefit.