Tris Pharma receives FDA approval for Dyanavel XR ADHD treatment

Tris Pharma receives FDA approval for Dyanavel XR ADHD treatment.

The U.S. Food and Drug Administration (FDA) recently approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children six years and older, according to an announcement from Tris Pharma Inc. on Tuesday.

Dyanavel XR is now the only once-a-day, extended-release, amphetamine-based oral liquid approved for children.

A Phase III study of 108 random children who met the DSM-IV criteria for ADHD showed positive results by meeting the goal of change from pre-dose to the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined score four hours after dosing.

"Amphetamines are well-established as effective treatment for ADHD," said Sally Berry, M.D., Ph.D., chief medical officer of Tris Pharma. "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."

As with all medication, there are possible risks, including, but not limited to, stroke and heart attack in adults who have taken Dyanavel.

"Tris Pharma is dedicated to addressing unmet medical needs through developing non-traditional oral extended-release formulations including oral suspensions, chewable tablets and oral disintegrating tablets," Ketan Mehta, president and CEO of Tris Pharma, said. "We are excited to receive FDA approval to commercialize Dyanavel XR, the sixth NDA approval in six years utilizing proprietary technology of Tris Pharma. We look forward to making Dyanavel XR available to physicians and patients in 2016."

 Please consult a doctor to find out if Dyanavel would be a good choice for you or your child.

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Tris Pharma ,

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903