COTEMPLA XR-ODT

COTEMPLA XR-ODT is a drug for which a New Drug Application (NDA 205489) was submitted on December 19, 2016, and received on the same date, with a PDUFA Goal Date of June 19, 2017. The application was designated as Standard. A partial waiver was granted for children aged 0-4 years with ADHD, and a deferral was issued for ADHD studies in children aged 4-6 years.

Efficacy findings from a randomized, multicenter, double-blind, placebo-controlled, parallel-group study (NT0102.1004) involving 87 children demonstrated that COTEMPLA XR-ODT was statistically significantly superior to placebo in SKAMP total score. The SKAMP-Combined score showed an LS mean difference of -11.0 compared to placebo, with an onset of efficacy at 1 hour and a duration of efficacy lasting 12 hours. Bioequivalence for Cmax, AUC0-3, AUC3-7, AUC7-12, and AUCinf was within 80-125%.

Safety findings indicated that common adverse events associated with methylphenidates include decreased appetite and weight, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, labile affect, agitation, irritability, dizziness, vertigo, tremor, blurred vision, increased blood pressure and heart rate, tachycardia, palpitations, hyperhidrosis, and pyrexia. In the NT0102 group during the double-blind phase, trichotillomania, cough, and epistaxis each occurred in 2.3% of subjects. No subjects reported suicidal ideation or behavior.