Tris Pharma acquires FDA OK for Dyanavel

The Food and Drug Administration has approved Tris Pharma's Dyanavel XR, or amphetamine, once-daily tablets for the treatment of attention-deficit hyperactivity disorder in patients age 6 years old and older.

The medication is a federally controlled substance.

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"The Dyanavel XR Tablet represents an important treatment option for patients with ADHD," said Andrew Cutler, CMO at the Neuroscience Education Institute and clinical associate professor of psychiatry at SUNY Upstate Medical University. "Knowing that ADHD in adults presents differently than in children, and as different adults have different treatment goals, Dyanavel XR once-daily tablet was designed and developed with the intent to provide adults with ADHD a treatment option that kicks in quickly and lasts throughout their workday and beyond."

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"The approval of Dyanavel XR tablets, which utilize Tris' LiquiXR technology platform, fills an important gap in Tris' portfolio of ADHD products to fit the needs of a variety of patient types," said Dr. James Hackworth, president of Tris branded products division. "Dyanavel XR oral suspension and now Dyanavel XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD."

Dyanavel XR tablets are expected to be stocked in pharmacies in the first quarter of 2022.