The Food and Drug Administration (FDA) has expanded the approval for Evekeo ODT (amphetamine sulfate; Arbor Pharmaceuticals) to include patients 3 to 5 years of age for the treatment of attention deficit hyperactivity disorder (ADHD). Previously, the treatment was indicated for patients 6 to 17 years of age.
Evekeo ODT, a Schedule II controlled substance, contains a 1:1 racemic mixture of dextroamphetamine sulfate and levoamphetamine sulfate. The expanded approval of Evekeo ODT is based on an adequate and well-controlled study with Evekeo immediate-release tablets for the treatment of ADHD in patients 3 years of age and older.
Switching from Evekeo to Evekeo ODT can be done on a mg-per-mg basis. Due to different amphetamine salt compositions and differing pharmacokinetic profiles, other amphetamine products cannot be substituted on a mg-per-mg basis. Prior to initiation, patients must be assessed for the presence of cardiac disease (eg, perform a careful history, family history of sudden death or ventricular arrhythmia, and physician exam).
Evekeo ODT will be supplied in a new 2.5mg orally disintegrating tablet for patients 3 to 5 years of age. The product is currently available as 5mg, 10mg, 15mg, and 20mg tablets in 30-count blister cards.
Evekeo ODT [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; 2021.