Pharma Trial Suggests Dyanavel XR Is Safe and Effective for Treating ADHD in Children
A medication manufacturer says recent studies show its recently released liquid ADHD medication can be used safely and effectively to treat children.
February 10, 2017
A new medication trial presents further evidence that Dyanavel XR — the only liquid amphetamine currently on the market to treat ADHD — is long lasting, effective, and safe for use in children, according to the medication’s manufacturer.
The company, Tris Pharma, Inc., presented the findings from its trial at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting in Washington, D.C. The trial involved 108 children between the ages of 6 and 12, all of whom had previously diagnosed ADHD. The children were given Dyanavel — though the materials released by the company don’t indicate at what doses — and tested in a “laboratory classroom” setting, a simulated school environment that allows researchers to observe children more naturally.
Compared to a placebo, Dyanavel was found to be effective at controlling symptoms of ADHD like hyperactivity, impulsivity, and inattention, starting from one hour after dosing and ending 13 hours after. Side effects were generally mild, and were comparable to other long-acting forms of amphetamine. The most common side effects included nosebleeds, allergic rhinitis (also known as hay fever), and slight abdominal pain.
“It’s important to establish and maintain effective control of symptoms in children with ADHD,” said Ann Childress, M.D., the lead presenter of the trial’s results. “This study demonstrates the effectiveness of Dyanavel XR in both onset of action at one hour post-dose, and a duration of efficacy extending to 13 hours post-dose.”
Dyanavel was approved by the FDA in October of 2015, and released to the public in April of 2016. As is the case with most stimulant medications, Tris Pharma advises patients with pre-existing heart conditions or high blood pressure exercise caution when using Dyanavel. Doses of Dyanavel start at 2.5 mg, and can be increased up to 20 mg per day if needed.
“Tris is committed to providing pediatric-friendly treatment options for children,” said Sally Berry, M.D., Ph.D., Chief Medical Officer for Tris Pharma, in a statement. “This work is evidence of our efforts to produce complete profiles of our pediatric products through robust research to inform clinical decision making.”