87 Efficacy Measures in an Open-label Dose-Optimization of an Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder.
CNS Spectr. 2019 Feb;24(1):218-219
Authors: Cutler A, Pardo A, King TR, Kando JC, Herman BK
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.
PMID: 30860000 [PubMed – in process]