Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD

Adelaide S. Robb, Robert L. Findling, Ann C. Childress, Sally A. Berry, Heidi W. Belden, Sharon B. Wigal

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To test whether an optimal dose of Quillivant XR (methylphenidate extended-release oral suspension [MEROS]) would significantly reduce symptoms of ADHD in children. Method: A randomized, double-blind, placebo-controlled, cross-over, efficacy, safety, and tolerability study of MEROS in 45 children aged 6 to 12 years (open-label dose-optimization phase, followed by double-blind cross-over period). Results: MEROS was significantly more efficacious than placebo during double-blind cross-over laboratory classroom days (Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale and Permanent Product Measure of Performance). During the open-label phase, improvements were observed in scores of ADHD Rating Scale-IV, and Clinical Global Impression-Severity and -Improvement Scales. No occurrences of suicidal ideation or behavior were recorded; the most common open-label treatment-emergent adverse events were typical of stimulant use: decreased appetite, insomnia, and abdominal pain. Conclusion: MEROS was efficacious in the treatment of children aged 6 to 12 years with ADHD, with a safety profile similar to that of other extended-release methylphenidate pharmacotherapies.

Original languageEnglish (US)
Pages (from-to)1180-1191
Number of pages12
JournalJournal of Attention Disorders
Volume21
Issue number14
DOIs
StatePublished - Dec 1 2017

Keywords

  • ADHD
  • laboratory school
  • math test
  • methylphenidate
  • randomized-controlled trial

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Clinical Psychology

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