Clinical Trials

Date: 2017-09-20

Type of information: Results

phase: 3

Announcement: results

Company: Shire (UK - USA) Shionogi (Japan)

Product: Intuniv® (guanfacine hydrochloride prolonged release)

Action mechanism:

• alpha2A-adrenergic receptor agonist. Guanfacine is a selective alpha2A-adrenergic receptor agonist which is expected to work by modulating the brain signalling pathways that are believed to be responsible for the symptoms associated with ADHD. It is expected to improve the symptoms of ADHD by initiating a response from neurons in regions of the brain associated with attention, organisation, planning and impulse control.

Disease: attention deficit hyperactivity disorder (ADHD)

Therapeutic area: Mental diseases - CNS diseases

Country: Japan

Trial details: This Phase 3 trial was a 12-week, randomized, double-blind, multi-center, parallel-group, placebo-controlled study in 201 adult patients (18 years old and over) with attention deficit hyperactivity disorder.

Latest news:

• • On September 20, 2017, Shire and its partner in Japan, Shionogi, announced that a phase 3 study evaluating Intuniv® (guanfacine hydrochloride prolonged release) in adult patients with attention deficit hyperactivity disorder 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 attention deficit hyperactivity disorder. 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. Intuniv® is currently approved as a treatment for child and adolescent patients (6 to 17 years old) in Japan.

Is general: Yes