www.fdanews.com/articles/176093-highland-therapeutics-adhd-drug-soars-in-phase-3
Highland Therapeutics’ ADHD Drug Soars in Phase 3
April 11, 2016
Highland Therapeutics’ investigational drug Benjorna achieved its primary endpoint, demonstrating a significant improvement in children between 6 and 12 with ADHD.
Results from the 153-patient study showed that children receiving the candidate experienced improved function in both morning and afternoon settings, meeting both primary and secondary endpoints.
The technology provides a delay in the initial release of the active drug, followed by a period of extended release to provide control of ADHD symptoms immediately upon wakening and throughout the day.
The company expects to file an NDA in mid-2016.