FDA Approves Liquid Extended-Release Amphetamine for Treatment of ADHD

The FDA announced that it has 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 FDA approval for treating ADHD.

In a Phase III clinical trial of 108 children aged 6 to 12 years, Dyanavel XR demonstrated a positive outcome by meeting its primary endpoint of change from pre-dose in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined score at 4 hours post-dosing. The medication also demonstrated an onset of clinical effect at 1 hour that lasted 13 hours.The most common adverse events reported by trial participants treated with the drug include epistaxis, allergic rhinitis, and upper abdominal pain.

Amphetamines are one among many treatment options available for treating ADHD in children. Generally speaking, behavioral therapy is recommended for those younger than age 6. For those aged 6—11, the use of medication in combination with behavior therapy is often recommended, with the evidence for stimulant medications being stronger in this age group than that for other classes. Children over the age of 12 may be treated with some combination of medication and behavioral therapy.

LiquiXR technology is a delivery system comprised of both immediate-release and extended-release amphetamine. By utilizing ion exchange polymeric chemistry, continuous release of amphetamine was achieved throughout the day. This liquid formulation masks the taste of the drug, is easier to swallow than tablets or capsules, and allows accurate dose adjustment, making it ideal for use in children.

“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” said Sally Berry, MD, PhD, Chief Medical Officer of Tris. “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.”

Although there is as yet limited experience with Dyanavel in clinical trials, the adverse reaction profile appears to be similar to other amphetamine extended-release products, which can include dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.