AYTUAYTU

AYTU (formerly Neos Therapeutics, Inc.) focuses on psychiatry. The company's drug, COTEMPLA XR-ODT, is a stimulant indicated for Attention Deficit Disorder in patients aged 6-17 years. The New Drug Application (NDA) for COTEMPLA XR-ODT was submitted on December 19, 2016, and received on the same date, with a PDUFA Goal Date of June 19, 2017. The FDA review was completed on May 12, 2017.

In Study NT0102.1004, a randomized, multicenter, double-blind, placebo-controlled, parallel group study, 7 subjects experienced irritability (TEAE) during the dose optimization/stabilization phase, representing 8%. During the double-blind phase of the same study, 1 subject in the NT0102 group experienced cough (TEAE), which was 2.3% of the MPH XR-ODT group. Epistaxis (TEAE) was observed in 1 subject (2.3%) in the NT0102 group during the double-blind phase. There were 3 subjects with clinically significant laboratory abnormalities in Study NT0102.1004. No subjects in Study NT0102.1004 reported suicidal ideation or behavior (C-SSRS). The FDA granted a Partial Waiver for children aged 0-4 years with ADHD and a Deferral for ADHD studies in children aged 4-6 years.