Tris Pharma announced that the Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged ≥6 years. Dyanavel XR is the only once-daily extended-release amphetamine-based oral liquid approved for ADHD in children.

The FDA’s approval was based on a Phase 3 randomized, placebo-controlled, laboratory classroom efficacy study (n=108) in children ages 6–12 years who met DSM-IV criteria for ADHD. The study consisted of a 5-week, open-label, dose optimization phase followed by a 1-week, double-blind treatment period. Study results showed a positive outcome by achieving the primary endpoint of change from pre-dose in the SKAMP-Combined score at 4 hours post-dose.

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Dyanavel XR, a central nervous system (CNS) stimulant, was developed using the Company’s patented LiquiXR technology, a platform that consists of both immediate-release and extended-release amphetamine. Its ion exchange polymeric chemistry allowed for continuous release of amphetamine throughout the day. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Dyanavel XR will be available as a 2.5mg/mL strength suspension in 464mL bottle. It is anticipated to launch in 2016.

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