Positive Ph III results with Highland Therapeutics' HLD-200 in ADHD

Ironshore Pharmaceuticals & Development, part of Canada-based specialty pharma company Highland Therapeutics, has reported positive top-line results from its recently completed Phase III study.

The study, a Phase III Clinical Endpoint Evaluation Study (CEES) examining the safety and efficacy of HLD-200, a novel formulations of the psychostimulant methylphenidate, in pediatric subjects with attention-deficit hyperactivity disorder (ADHD), was conducted at four centers in the USA. The trial enrolled 43 pediatric patients between the ages of six and 12. Following a six-week open label, treatment-optimization phase, subjects then entered into a double-blind, placebo-controlled, one-week randomized, parallel-group test period designed to assess the safety and efficacy of HLD-200 treatment.

Primary endpoint met