title: Pharmacokinetics of a Novel Amphetamine Extended-Release Orally Disintegrating Tablet in Children with Attention-Deficit/Hyperactivity Disorder.
abstract: BACKGROUND
  A novel formulation for treating attention-deficit/hyperactivity disorder (ADHD) has recently been developed-amphetamine extended-release orally disintegrating tablets (AMP XR-ODTs). In this study, we assessed the rate of absorption and exposure of AMP XR-ODT under fasted conditions in children with ADHD.
  
  
  METHODS
  Children (6-12 years) with ADHD were enrolled in a single-dose, open-label, single-period pharmacokinetic (PK) study. Patients were stratified by age (6-7, 8-9, and 10-12 year olds) and were dosed with 18.8-mg AMP XR-ODT under fasted conditions. Plasma samples were analyzed for d-and l-amphetamine. Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve from time zero-infinity (AUCinf), weight-normalized clearance (CL/F), and weight-normalized volume of distribution (Vz/F) were assessed. The geometric mean and 95% confidence intervals (CIs) were calculated for weight-normalized CL/F and Vz/F in each age group to determine if the 95% CIs were within the target range of 60%-140%.
  
  
  RESULTS
  A total of 28 children completed the study. The 95% CIs for the geometric mean CL/F/kg and Vz/F/kg for both d- and l-amphetamine fell within the target range of 60%-140% for each age group, thus meeting the primary end point. Four participants experienced treatment-related adverse events, including vomiting (n = 3), abdominal pain (n = 2), dry mouth (n = 1), and insomnia (n = 1).
  
  
  CONCLUSIONS
  AMP XR-ODT, a novel formulation that does not require swallowing an intact tablet or capsule, was well tolerated and demonstrated a PK profile consistent with once-daily dosing in children with ADHD.
authors.affiliation: 1 Worldwide Clinical Trials , Austin, Texas.
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Stark
authors.affiliation: 2 Neos Therapeutics, Inc. , Grand Prairie, Texas.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Engelking
authors.affiliation: 2 Neos Therapeutics, Inc. , Grand Prairie, Texas.
authors.forename: Russ
authors.initials: R
authors.lastname: McMahen
authors.affiliation: 2 Neos Therapeutics, Inc. , Grand Prairie, Texas.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Sikes
mesh_terms: D000661:Amphetamine / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D001835:Body Weight; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002648:Child; D003692:Delayed-Action Preparations; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D013237:Stereoisomerism; D013607:Tablets
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D013607:Tablets; D000661:Amphetamine
keywords: amphetamine extended-release orally disintegrating tablets; attention-deficit/hyperactivity disorder; pharmacokinetics in children; stimulants