FDA Approves Liquid ADHD Treatment for Kids
The FDA today approved Tris Pharma's extended-release amphetamine oral suspension (Dyanavel XR) for the treatment of ADHD in children aged 6 years and older.
The FDA today approved Tris Pharma’s extended-release amphetamine oral suspension (Dyanavel XR) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older.
The drug, developed using the manufacturer’s LiquiXR technology, is now the first and only once-daily, extended-release, amphetamine-based oral liquid to be granted the FDA’s nod for this purpose.
Today’s approval follows Tris’ submission of a New Drug Application for Dyanavel XR, which was supported by data from a phase 3 study that tested the drug’s safety and efficacy in 108 children aged 6 to 12 years. In the trial, Dyanavel XR demonstrated an onset of clinical effect at 1 hour that lasted 13 hours.
“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” said Tris Chief Medical Officer Sally Berry, MD, PhD, in a press release. “Amphetamines are well-established as effective treatment for ADHD. 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.”
The most common adverse events reported by trial participants treated with the drug include epistaxis, allergic rhinitis, and upper abdominal pain.