FDA okays once-daily amphetamine for ADHD in children

FDA approved amphetamine (Dyanavel XR—Tris Pharma), an extended-release oral suspension for the treatment of ADHD in children aged 6 years and older.

FDA approved amphetamine (Dyanavel XR—Tris Pharma), an extended-release oral suspension for the treatment of ADHD in children aged 6 years and older. According to Tris Pharma, the approval is based on a Phase III study of 108 children with ADHD that demonstrated the primary endpoint of change from predose in the SKAMP-Combined score at 4 hours post dosing. In addition, the study met the secondary endpoint of an onset of clinical effect at 1 hour that lasted through 13 hours post dosing, compared with placebo. Adverse events reported during the study included epistaxis, allergic rhinitis, and upper abdominal pain. "Dyanavel XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children," said Sally Berry, chief medical officer of Tris.