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Psych Congress  

Safety Findings of a Phase 3 Study of HLD200 in Children with Attention-Deficit/Hyperactivity Disorder

Sharon Wigal, PhD
Ann Childress, MD
Mary Ann McDonnell, PhD
Scott Kollins, PhD
Bert DeSousa, MA
F. Randy Sallee, MD, PhD
Ironshore Pharmaceuticals & Development, Inc.

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Objective: This 7-week phase 3 trial evaluated the safety and efficacy of evening-dosed HLD200, a novel delayed-release and extended-release methylphenidate formulation designed to control symptoms upon awakening and throughout the day, in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: This study consisted of a 6-week open-label, treatment optimization phase followed by a 1-week randomized, double-blind, placebo-controlled, parallel-group phase. During the first week of the treatment optimization phase, subjects initiated HLD200 at their previous methylphenidate dose equivalent. Over the subsequent five weeks, dosage was adjusted to achieve optimal symptom control. During the double-blind phase, subjects were randomized to either HLD200 or placebo. Safety endpoints are reported herein.

Results: Forty-three subjects were included and treated with HLD200 for approximately 1,950 patient-days. Mean starting dose was 33.0 mg, and mean optimal dose achieved at the end of the open-label phase was 65.6 mg. There were no serious treatment-emergent adverse events (TEAEs) throughout the study and no TEAEs leading to early withdrawal. During the open-label phase, 121 TEAEs were reported in 38 subjects (88%), with decreased appetite (35%), headache (16%), insomnia (16%), upper abdominal pain (14%), and irritability (12%) being the most commonly reported. In the double-blind phase, there were no appetite-related TEAEs in either study group, and no sleep-related TEAEs in the HLD200-treated group. There were 7 HLD200- and 7 placebo-treated subjects (32% and 33%, respectively) who experienced a TEAE, with headache being the most commonly reported (HLD200: 9%; placebo: 10%).

Conclusions: HLD200 demonstrated a favorable tolerability and safety profile in children with ADHD.

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