NEOS THERAPS INC — Cotempla Xr-Odt FDA Review (NDA205489, ORIG 1, 2017)
NEOS THERAPS INC · 2017 · FDA Review (openFDA) · company profile →
Report summary
NEOS Therapeutics' Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) demonstrated superiority over placebo in pediatric ADHD patients (6-12 years). The drug significantly reduced SKAMP-Combined scores by an estimated 11 points compared to placebo. Efficacy was observed from 1 hour to 12 hours post-dose, confirmed by sensitivity analyses and PERMP endpoints. While subgroup analyses by age and gender showed favorable trends, definitive conclusions were limited by sample size.
Key findings — cited to the page
| Study initiation date | 07/17/2013 | NT0102.1004 · p.10 |
| Percentage of males in study | 65.9 % | · p.18 |
| Mean age | 9.2 years | · p.18 |
| Age range | 6 to 12 years | · p.18 |
| Percentage of White subjects | 79.3 % | · p.19 |
| Percentage of Black or African American subjects | 12.2 % | · p.19 |
| Percentage of Hispanic or Latino subjects | 34.1 % | · p.19 |
| Treatment effect on SKAMP-Combined score (LS mean difference vs placebo) | -11.0 | · p.22 |
| NDA number | 205489 | Cotempla XR-ODT · p.2 |
| PDUFA date | 06/19/2017 | Cotempla XR-ODT · p.2 |
| Review Priority | Standard | · p.2 |
| Age range of subjects | 6-12 years | NT0102.1004 · p.11 |
Source: NEOS THERAPS INC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →