Knight Therapeutics has forged an exclusive agreement with Supernus Pharmaceuticals to secure a licence for Qelbree (viloxazine extended-release capsules) in Canada.

Supernus is an American biopharmaceutical company focused on the development and commercialisation of products to treat central nervous system (CNS) diseases.

Qelbree is an extended-release formulation of viloxazine, which is a multimodal serotonergic and norepinephrine modulating agent (SNMA).

It is a nonstimulant medicine to treat Attention-Deficit Hyperactivity Disorder (ADHD).

Under the agreement, Supernus Pharmaceuticals has granted Knight the right to seek regulatory approval and commercialise Qelbree in Canada.

The financial terms of the agreement were not disclosed.

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

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

Qelbree is a commercially available prescription medication in the US to treat ADHD.

It was approved by the US Food and Drug Administration in 2021 for the treatment of children aged six to 17 years and in 2022 for the treatment of adults, based on the findings of four pivotal trials.

Additionally, Qelbree is presently being investigated in multiple Phase 4 clinical trials.

The first trial involves treating children and adolescents with ADHD in combination with psychostimulants. The study’s favourable topline results were announced in September 2023.

In January 2024, a second phase 4 clinical trial involving preschool-aged children with ADHD is scheduled to start.

Furthermore, Qelbree is being evaluated for its effect on co-morbid mood symptoms that are common in ADHD patients in a third confirmatory clinical trial.

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