New Phase III data for Cotempla XR-ODT (extended release methylphenidate) for children with ADHD- Neos Therapeutics

Neos Therapeutics has announced the presentation of new data from a clinical trial of orally disintegrating tablet Cotempla XR-ODT (extended release methylphenidate) for children with ADHD. In the Phase III randomised, multicentre, double-blind, placebo-controlled, parallel group study of 87 children with ADHD, treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day in children with ADHD, as defined by the SKAMP-Combined score scale.

The SKAMP-Combined scores averaged over the classroom testing day were 14.3 for the Cotempla XR-ODT group and 25.3 for the placebo group. Onset of treatment effect based in the SKAMP-combined score was observed as early as one hour post-dose and was sustained through 12 hours post-dose. The most common TEAEs during the study (more than 5% in any study period) were decreased appetite, upper abdominal pain, headache, insomnia, upper respiratory tract infection, affect lability, irritability, cough, and vomiting. Most AEs were mild in intensity. The results were presented at the American Academy of Child and Adolescent Psychiatry's 62nd Annual Meeting in San Antonio, Texas.