April 20, 2016
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Dyanavel XR now available for ADHD in US

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Tris Pharma Inc. recently announced the launch of Dyanavel XR, extended-release oral suspension, CII, for attention-deficit/hyperactivity disorder in children aged 6 years and older.

Dyanavel XR, an extended-release liquid amphetamine, is now available by prescription only in U.S. pharmacies.

Ann C. Childress, MD

Ann Childress

The treatment received FDA approval in October 2015, based on results from a phase 3 randomized, placebo-controlled, laboratory classroom efficacy study among 108 children aged 6 to 12 years who met DSM-IV criteria for ADHD.

“Dyanavel XR was evaluated in a laboratory classroom setting in children with ADHD aged 6 to 12 years and was shown to improve attention and behavior and helped decrease impulsivity and hyperactivity,” study researcher Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, said in a press release. “Dyanavel XR demonstrated a statistically significant difference vs. placebo starting at 1 hour and lasting up to 13 hours after dosing, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale.”

The most common adverse reactions, which occurred in 2% or fewer children receiving Dyanavel XR, included epistaxis, allergic rhinitis and upper abdominal pain.

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