Knight Therapeutics Moves Forward with Qelbree Approval in Canada

Knight Therapeutics Advances ADHD Treatment Options

Knight Therapeutics Inc. (TSX: GUD) is making strides in the field of attention-deficit hyperactivity disorder (ADHD) treatment with the recent announcement regarding Qelbree (viloxazine). The company revealed that its New Drug Submission (NDS) for Qelbree has been accepted for review by Health Canada. As a novel, nonstimulant medication, Qelbree offers an exciting treatment avenue for individuals diagnosed with ADHD.

Exclusive Rights with Supernus Pharmaceuticals

In a notable development in December, Knight Therapeutics partnered with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) to secure exclusive commercialization rights for Qelbree in Canada. This product has been accessible in the United States as a prescription medication for the treatment of ADHD, aimed at patients aged six and older. Qelbree's journey towards becoming an approved option in Canada is bolstered by crucial supportive data from pivotal clinical trials that demonstrated its effectiveness.

Approved and Currently Studied

Qelbree received approval from the U.S. Food and Drug Administration in April 2021 for treatment in children aged 6 to 17, with further approval extended to adults in April 2022. This medication is currently the focus of various clinical studies, with one trial investigating its use alongside psychostimulants for children and adolescents showing promising topline results reported recently. Further trials are underway, including studies concerning preschool-age children and adults experiencing ADHD with co-morbid mood symptoms.

Innovative Approach to ADHD Treatment

Samira Sakhia, President and Chief Executive Officer of Knight, expressed enthusiasm for the Canadian submission of Qelbree, highlighting its importance as a new nonstimulant treatment for ADHD. This novel approach aims to address the medical community's need for alternatives to traditional stimulant therapies, especially for patients who do not respond well to them. With the introduction of Qelbree, Knight is actively working to enhance its ADHD product portfolio, offering diverse options tailored to meet the varying needs of patients.

Market Insights and Growth

According to recent data from IQVIA Canada, the market for non-stimulant ADHD products in Canada reached a notable value of $83.5 million in the recent past. Furthermore, there has been a continuous growth trend in this sector, with prescriptions in the non-stimulant ADHD market rising by 10% in one year and showcasing a compound annual growth rate of 11% over four years. Such insights underline the increasing demand for ADHD treatment alternatives, positioning Qelbree as a crucial addition to the market.

Understanding ADHD Importance

ADHD is a neurodevelopmental disorder that affects both children and adults, signifying a significant health concern due to its impact on daily functioning. The prevalence of ADHD varies, with estimates suggesting 5-9% in children and adolescents and 3-5% among adults. The disorder is marked by symptoms such as inattention, hyperactivity, and impulsivity, often requiring ongoing management and treatment. While traditional treatments involve various psychostimulants and long-acting non-stimulant options, not everyone benefits from existing therapies, emphasizing the necessity for new treatment solutions.

About Knight Therapeutics Inc.

Situated in Montreal, Canada, Knight Therapeutics Inc. focuses on acquiring, in-licensing, and commercializing pharmaceuticals tailored for Canada and Latin America. Its subsidiaries operate under various branding, including United Medical and Biotoscana Farma. Knight's shares are publicly traded under the ticker GUD, reflecting its ongoing commitment to improving healthcare options across the regions it serves.

Frequently Asked Questions

What is Knight Therapeutics Inc. known for?

Knight Therapeutics is recognized for its focus on specialty pharmaceuticals, specifically aimed at addressing unmet medical needs in ADHD treatment and other areas across Canada and Latin America.

What is Qelbree used for?

Qelbree is a novel nonstimulant medication used for treating attention-deficit hyperactivity disorder (ADHD) in both children and adults.

Why is the submission for Qelbree significant?

The submission for Qelbree is significant as it represents a new treatment option for patients with ADHD who may not respond positively to traditional stimulant medicaments.

How is Qelbree different from stimulants?

Qelbree differs from traditional stimulants as it offers a nonstimulant alternative, which can be beneficial for patients who have had suboptimal results with stimulant medications.

What are Knight's future plans concerning Qelbree?

Knight aims to enhance its ADHD portfolio by expanding the availability of Qelbree while exploring additional treatments that could address various patient needs within the domain of ADHD management.

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