The U.S. Food and Drug Administration accepted for review Supernus Pharmaceuticals Inc.'s application for attention deficit hyperactivity disorder drug SPN-812.
The drug is intended for the treatment of children and adolescents with ADHD. Symptoms of the disorder include difficulty paying attention, being overactive and acting impulsively.
The regulator is expected to make a decision by Nov. 8.
Rockville, Md.-based Supernus' new drug application is backed by data from four phase 3 clinical studies, two mid-stage ones and several phase 1 trials. Results from the studies showed the medication reduced ADHD symptoms such as hyperactivity, impulsive behavior and inattention in children.
The company started another phase 3 trial of SPN-812 in adult ADHD patients in late 2019.
Supernus Pharmaceuticals develops and commercializes products to treat central nervous system diseases in the U.S.