87 Efficacy Measures in an Open-label Dose-Optimization of an Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder

Abstract

OBJECTIVES: Report the efficacy of open‐label amphetamine extended‐release oral suspension (AMPH EROS) for the treatment of children with ADHD.AMPH EROS has a 1‐hr onset of effect and a duration of action of 13hours and was approved by FDA for treatment of ADHD in children aged 6‐17 years based on a double‐blind, placebo‐controlled efficacy and safety study in children aged 6‐12 years with ADHD. A significant treatment difference in change from pre‐dose SKAMP‐combined score was observed at the primary endpoint of 4hours post‐dose (p5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings and headache. CONCLUSION: AMPH EROS was effective in reducing symptoms of ADHD in this open‐label dose optimization. The AE profile of AMPH EROS was consistent with those of other amphetamine products.Funding Acknowledgements: This work was funded by Tris Pharma, Inc.