Phase III study of Intuniv (guanfacine hydrochloride prolonged release) meets primary endpoint in adults with attention deficit hyperactivity disorder.- Shire + Shionogi.

Shire and Shionogi announced that a Phase III study evaluating Intuniv (guanfacine hydrochloride prolonged release) in adult patients with attention deficit hyperactivity disorder (ADHD) in Japan has positive topline results, and the study met the primary endpoint. This is the first clinical trial evaluating Intuniv in adult patients (18 years old and over) with ADHD.

The primary efficacy analysis demonstrated that Intuniv (4 to 6mg), administered as a once-daily dose, was superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (ADHD-RS-IV with adults prompts) total score. Intuniv also demonstrated nominal significance over placebo at the end of treatment on the clinically important secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), suggesting more patients achieved a marked clinical improvement in global functioning.

Treatment-emergent adverse events in the study were generally mild to moderate in severity and similar to those observed in previous Intuniv studies with no new or unexpected safety findings. Treatment emergent adverse events reported at more than or equal to 10% for Intuniv were somnolence, dry mouth, blood pressure decrease, nasopharyngitis, dizziness postural and constipation. 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.