FDAnews
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.