Amphetamine extended-release oral suspension for attention-deficit/hyperactivity disorder

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder known to respond to amphetamine (AMPH). Multiple AMPH formulations have been developed during the past two decades and have focused mainly on extending the duration of effect. AMPH extended-release oral suspension, Dyanavel XR, (AMPH EROS) was developed to address the unmet needs of patients who have difficulty swallowing intact extended-release (ER) tablets and capsules. Areas covered: The pharmacokinetic profile of the AMPH EROS in children and adults is discussed along with the technology responsible for its release profile. Efficacy data from two clinical trials are presented and AMPH EROS is compared with other marketed AMPH ER formulations in the United States. Expert opinion: Multiple AMPH ER formulations that do not require ingestion of an intact tablet or capsule have been developed. Initial products allowed for sprinkling or dissolving of capsule contents. Recently, oral disintegrating tablets, chewable tablets, and oral suspensions have been marketed. Each formulation has positive attributes. Tablets may be more portable. However, as a suspension, AMPH EROS dosing can differ depending on daily requirements. Dose can also be titrated with a single prescription. Despite its convenience, AMPH EROS is a branded product, so price may be prohibitive for some patients.