Tris Pharma has announced the launch of Dyanavel XR (amphetamine), the first extended-release liquid amphetamine for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 years and older.
Approval for Dyanavel XR was granted by the FDA in October 2015, based upon a Phase 3 controlled study. When Dyanavel XR was compared to placebo – in the study – there was significant difference in improvement of attention and behavior, and decreasing of impulsivity and hyperactivity.
“Dyanavel XR was evaluated in a laboratory classroom setting in children with ADHD aged 6 to 12 years and was shown to improve attention and behavior and helped decrease impulsivity and hyperactivity,” said Ann Childress, M.D., lead investigator and President of the Center for Psychiatry and Behavioral Medicine, Las Vegas. “Dyanavel XR demonstrated a statistically significant difference versus placebo starting at one hour and lasting up to 13 hours after dosing, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP).”
The most common side effects reported in the Phase 3 study were epistaxis (nosebleed), allergic rhinitis, and upper abdominal pain.
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. They 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, a CII, is available in an extended-release oral suspension that contains 2.5mg of amphetamine base per mL. It is packaged in bottles of 464mL and comes in a bubblegum flavor.
For more information visit TrisPharma.com.