Shire Reports New Data From INTUNIV Study

Shire has reported study results on INTUNIV (guanfacine) Extended Release Tablets. INTUNIV was recently approved by the FDA as the first nonscheduled alpha-2A agonist indicated for the treatment of ADHD in children and adolescents.

The primary objective of this study was to assess the change from baseline on the oppositional subscale of the Conners’ Parent Rating Scale-Revised: Long Form (CPRS-R:L) in patients ages 6 to 12 with a primary diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), with the presence of oppositional symptoms at baseline.

According to the Centers for Disease Control and Prevention (CDC), approximately 7.8% of all US school-aged children have been diagnosed with ADHD at some point in their lives. ADHD is a complex neurobehavioral disorder, which includes symptoms and behaviors such as inattentiveness, running around or climbing excessively, and being excitable or impulsive, many of which can be disruptive

Randy Sallee, Professor of Psychiatry at the University of Cincinnati and Cincinnati Children’s Hospital Medical Center in Cincinnati, said: “The disruptive nature of ADHD can impact social and academic settings for those patients diagnosed with the disorder. This study showed that INTUNIV is an effective option for treating a range of ADHD symptoms.”

Although the mechanism of action is not known, guanfacine, the active ingredient in INTUNIV, is thought to selectively stimulate alpha-2A adrenoreceptors in the prefrontal cortex. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.

INTUNIV is expected to be available in US pharmacies in November and will come in four dosage strengths (1mg, 2mg, 3mg, and 4mg).