In Japan, positive topline data from Phase III trial in ADHD

Ireland-incorporated Shire and its Japanese partner Shionogi have announced positive topline data from a Phase III study of Intuniv (guanfacine hydrochloride prolonged release) in adult patients with attention deficit hyperactivity disorder (ADHD).

The study met its primary endpoint of superiority to placebo on a commonly-used ADHD evaluation metric. The drug was administered as a once-daily dose.

The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of an illness, change over time and response to treatment.

The companies say treatment-emergent adverse events in the study were generally mild to moderate in severity.

Shire Japan and Shionogi will evaluate the full data, and will communicate plans for publication or presentation of the data, as well as potential milestones for the continued development of Intuniv in adults with ADHD.