Knight Therapeutics and Supernus Pharma Ink Pact To Treat CNS Ailments

Knight Therapeutics Inc announced an exclusive license agreement with Supernus Pharmaceuticals Inc, a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, granting Knight the rights to seek regulatory approval and commercialize Qelbree® in Canada. Qelbree® is an extended-release version of viloxazine, a nonstimulant medicine for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) that is a multimodal serotonergic and norepinephrine modulating agent (SNMA). The agreement's financial specifics 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,1-4 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, as per Knight Therapeutics.

Qelbree® is also being researched in multiple phase 4 clinical trials5, the first of which is for the treatment of children and adolescents with ADHD in combination with psychostimulants (positive topline findings released in September 20236). among January 2024, a second phase 4 clinical trial7 among preschool-aged children with ADHD is scheduled to begin. A third phase clinical trial9 is investigating the effect of Qelbree® on co-morbid mood problems common in ADHD patients.

“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,” said Samira Sakhia, President and CEO of Knight. “We are excited to pursue regulatory approval and bring a novel nonstimulant medication to enhance treatment of patients living with ADHD.”