Green Light for Kid-Friendly ADHD Rx

Dyanavel XR (once-daily liquid amphetamine), from Tris Pharma, approved to treat ADHD

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) There's a new medication option for young ADHD patients who may not be able to swallow pills.

It's called Dyanavel XR, and it just received approval from the US Food and Drug Administration (FDA).

"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 Pharma, which produces the new drug, 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."

ADHD (attention deficit hyperactivity disorder) is a chronic condition marked by hyperactivity, trouble paying attention and impulsive behavior. Around 11 percent of children between 4 and 17 years old have an ADHD diagnosis, according to 2011 data from the Centers for Disease Control and Prevention. Young children often have trouble swallowing pills — something that created a need for an effective liquid medication for pediatric ADHD patients, according to Tris Pharma.

The FDA gave its nod of approval to Dyanavel XR after the drug appeared safe and effective in a five-week, placebo-controlled trial involving 108 children. Adverse reactions included stomach pain, nose bleeds and allergic rhinitis (often referred to as hay fever).

Dyanavel XR is a once-daily liquid ADHD treatment. According to Tris Pharma, the new drug achieves both immediate and extended release during the day through a patented company technology called LiquiXR.

Review Date: 
October 21, 2015
Last Updated:
October 26, 2015