Abstract

Amphetamine extended-release oral suspension (Adzenys ER™) and extended-release orally disintegrating tablets (Adzenys XR-ODT®) are easy-to-administer, long-acting, and convenient CNS stimulant options for treating attention-deficit hyperactivity disorder (ADHD) in children aged ≥ 6 years, adolescents, and adults. The bioavailability of d- and l-amphetamine with Adzenys ER™ suspension and XR-ODT® is equivalent to that of a corresponding dose of the reference product [i.e. mixed amphetamine salt extended-release capsules (MAS ER)], which has well-established efficacy, tolerability, and safety profiles. As Adzenys ER™ suspension/XR-ODT® contain both immediate- and extended-release amphetamine particles, plasma concentrations of d- and l-amphetamine increase rapidly, remain relatively stable for several hours, then slowly decline, allowing for once-daily administration. The use of Adzenys ER™ suspension/XR-ODT® may be of particular benefit in individuals who require a rapid onset and prolonged reduction in ADHD symptoms, as well as those who have difficulty swallowing tablets or capsules whole (neither formulation requires swallowing whole tablets/capsules, and both may be taken without regard to food).

Full Text
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