Second Phase III trial starts for HLD 200 for treatment of ADHD- Highland Therapeutics

A pivotal trial will enroll approximately 150 pediatric patients between the ages of six and twelve across seven sites in the U.S. The study will utilize an open-label, treatment-optimization phase, followed by a double-blind, placebo-controlled, 1-week, parallel-group study design to assess safety and tolerability as well as the time-course of treatment effect of evening-dosed HLD 200 from Highland Therapeutics, in pediatric subjects diagnosed with ADHD. The study has been designed to build upon the successful results of the exploratory Phase III trial, known as CEES (Clinical EndpointEvaluation Study), which was completed in 2014. The primary objective of the study is to assess whether prior-evening treatment with HLD-200 improves control of ADHD symptoms, compared with placebo, from 8:00am to 8:00pm in pediatric subjects with ADHD.

Earlier results support the idea that it is possible to formulate a stimulant intended for nighttime dosing to achieve meaningful controls over ADHD symptoms upon waking and throughout the day. According to a Highland Therapeutics sponsored survey, families report challenges of uncontrolled symptoms of ADHD during the early morning routine with 55% reporting the level of impairment as severe or moderate to severe.