Knight Therapeutics Inc. announced that it has entered into an exclusive license agreement with Supernus Pharmaceuticals, Inc., granting Knight the rights to seek regulatory approval and commercialize Qelbree in Canada. Qelbree is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed.

Qelbree (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials, Qelbree® was approved by the US Food and Drug Administration in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. Qelbree is also currently being studied in several phase 4 clinical trials, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023).

A second phase 4 clinical trial in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial9 is studying the impact of Qelbree® on co-morbid mood symptoms prevalent in patients with ADHD.