NEOS THERAPS INC — Cotempla Xr-Odt FDA Review (NDA205489, ORIG 1, 2017)
NEOS THERAPS INC · 2017 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed Neos Therapeutics' NDA for COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets) for ADHD in pediatric and adolescent patients aged 6-17. A previous Complete Response was issued due to bioinequivalence between clinical trial and commercial formulations, necessitating a bridging bioavailability/bioequivalence study (NT0102.1005). Despite this, a Phase 3 study (NT0102.1004) demonstrated the drug's statistical superiority over placebo in reducing ADHD symptoms in children aged 6-12, with an onset of effect at 1 hour and duration up to 12 hours. Safety studies showed common adverse events consistent with other methylphenidate products (e.g., decreased appetite, headache, tachycardia), with no new safety signals, deaths, or serious adverse events. The FDA recommends approval, citing a safety profile similar to other extended-release methylphenidates.
Key findings — cited to the page
| Irritability (TEAE) during dose optimization/stabilization phase | 7 | Study NT0102.1004 · p.42 |
| Irritability (TEAE) during dose optimization/stabilization phase | 8 % | Study NT0102.1004 · p.42 |
| Cough (TEAE) in NT0102 group during double-blind phase | 1 | Study NT0102.1004 · p.42 |
| Epistaxis (TEAE) in NT0102 group during double-blind phase | 1 | Study NT0102.1004 · p.42 |
| Epistaxis (TEAE) in NT0102 group during double-blind phase | 2.3 % | Study NT0102.1004 · p.42 |
| Subjects with clinically significant laboratory abnormalities | 3 | Study NT0102.1004 · p.42 |
| Waiver for children age 0-4 years of age with ADHD | Partial Waiver | · p.45 |
| Subjects with suicidal ideation or behavior (C-SSRS) | 0 | Study NT0102.1004 · p.43 |
| Deferral for ADHD studies in children (4-6 years old) | Deferral | · p.45 |
| Application Type | NDA | COTEMPLA XR-ODT · p.2 |
| Application Number | 205489 | COTEMPLA XR-ODT · p.2 |
| Cough (TEAE) in NT0102 group during double-blind phase | 2.3 % | Study NT0102.1004 · p.42 |
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 →