Shire reports positive data from Phase III trial of Intuniv for ADHD

Irish biotechnology firm Shire and its Japanese partner Shionogi have reported positive top-line results from a Phase III clinical trial of Intuniv (guanfacine hydrochloride prolonged release) in adults with attention deficit hyperactivity disorder (ADHD).

Intuniv is a non-stimulant and selective agonist of alpha-2A adrenergic receptor agonist being developed as a potential treatment for ADHD in children and adults in Japan.

The trial has met the primary endpoint, showing superiority over placebo in change from baseline on a clinically administered ADHD rating scale (ADHD-RS-IV) total score.

With a total of 201 Japanese subjects aged 18 and above, the randomised, double-blind, multi-centre, parallel-group, placebo-controlled Phase III trial assessed 4mg-6mg of once-daily Intuniv.

Shire neuropsychiatry global clinical development vice-president and head Brigitte Robertson said: “The positive top-line results of this Phase III study provide us with important data and insights regarding the clinical profile of Intuniv in adult patients with ADHD.

“We are evaluating the full data set, and excited to advance the development of Intuniv as a non-stimulant treatment option for adults with ADHD in Japan, building on the established efficacy and safety data for ADHD in child and adolescent patients.”

The results also showed that more patients treated with Intuniv demonstrated a significant clinical improvement in global functioning, compared to placebo.

During the trial, treatment-emergent adverse events were found to be mild-to-moderate and consistent with those observed during prior studies of Intuniv.

The events reported at equal to or greater than 10% included somnolence, dry mouth, blood pressure decrease, nasopharyngitis, dizziness postural and constipation.

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Image: ADHD could have an impact on schooling, work and employment, behaviour and social functioning. Photo: courtesy of Masae.