The trial is a proof-of-concept, open-label study with pediatric subjects randomized according to weight group and titrated to receive one of four doses over a six-week treatment period. The primary objective is to measure safety and tolerability, with a secondary measure of efficacy in reducing symptoms of serious conduct problems.
SPN810 is a molecule that has been previously approved in the US for treatment of other indications. It has a mechanism of action that is promising for the treatment of aggression and serious conduct problems, the company said.
Jack Khattar, president and CEO of Supernus, said: “Currently there are no products approved for conduct disorder in the setting of attention-deficit hyperactivity disorder (ADHD), and SPN810 represents a novel approach to addressing this unmet medical need. We are excited about the potential of SPN810 and the advancement it may represent for ADHD patients with this condition.”