Tris developed Dyanavel XR using its patented LiquiXR™ technology, 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.
"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."
"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," said Ketan Mehta, President and CEO of Tris Pharma. "We are excited to receive FDA approval to commercialize Dyanavel XR, the 6th 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."
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