Knight Therapeutics has signed an exclusive licence agreement with Supernus Pharmaceuticals for the attention-deficit hyperactivity disorder (ADHD) treatment Qelbree (viloxazine) in Canada.

Knight will hold the rights to seek regulatory approval and sell the non-stimulant ADHD therapy to this market.

An extended-release viloxazine formulation, Qelbree is intended for treating ADHD, a neurodevelopmental disorder that impacts children and adults.

The therapy works as a multimodal serotonergic and norepinephrine modulating agent, providing an alternative to stimulant ADHD medications.

Qelbree received approval from the US Food and Drug Administration in 2021 for use as a prescription ADHD therapy for patients aged six to 17 years and was approved for use in adults last year. 

The approvals are based on data from several pivotal trials of Qelbree.

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The non-stimulant is being analysed in Phase IV trials, including in a study along with psychostimulants for use in children and adolescents.

A Phase IV trial focusing on preschool children is set to begin in January 2024.

A further trial will assess the effect of Qelbree on co-morbid mood symptoms commonly linked to ADHD.

Knight president and CEO Samira Sakhia stated: “This partnership represents the continued execution of our strategy of expanding our presence in CNS [central nervous system] and entering one of the most important segments still presenting relevant unmet medical needs. 

“We are excited to pursue regulatory approval and bring a novel non-stimulant medication to enhance the treatment of patients living with ADHD.”

Financial details of the licence deal between Knight and Supernus were not disclosed.

The agreement will bolster Knight’s portfolio and offer a new therapeutic option for ADHD patients in Canada.

Supernus Pharmaceuticals president and CEO Jack Khattar stated: “Supernus was able to identify in Knight the right commercial experience and capabilities to get Qelbree approved and successfully launch it in Canada. 

“Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD.”