Date: 2012-02-06
Type of
information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of the American Academy of Child & Adolescent Psychiatry
Company: Shire (UK)
Product: Intuniv® (guanfacine)
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) in children and adolescents ages 6 to 17
Therapeutic
area: Mental diseases - CNS diseases
Country:
Trial
details:
Latest
news:
- Shire has announced the publication of data for once-daily Intuniv® (guanfacine) Extended-Release Tablets as adjunctive therapy to stimulants for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17 in the Journal of the American Academy of Child & Adolescent Psychiatry. Findings show that treatment with Intuniv® given in combination with a stimulant led to significant improvements in ADHD symptoms from baseline as measured by ADHD Rating Scale IV (ADHD-RS-IV) total score, the primary efficacy measure of the study.
- During the 9-week, multicenter, double-blind, randomized, placebo-controlled study, patients (N=455) experiencing a suboptimal response* to stimulant treatment for ADHD were randomized to receive a morning or evening dose of Intuniv® (1 mg, 2 mg, 3 mg, or 4 mg) or placebo in combination with their prescribed dose of a stimulant.1 Clinicians reported significantly greater improvement from baseline to endpoint in ADHD-RS-IV total score, which includes both hyperactive/impulsive and inattentive subscales, in patients receiving Intuniv® and a stimulant, when Intuniv® was dosed either in the morning or evening, compared with patients receiving placebo and stimulant.
- The most commonly observed adverse reactions (incidence greater than or equal to 5 percent and at least twice the rate for placebo) in this adjunctive trial were somnolence, fatigue, insomnia, dizziness, and abdominal pain. The majority of events were mild or moderate in severity and no unique events were observed with Intuniv® given with a stimulant compared with those reported historically for either treatment alone. There were no serious treatment-related adverse events seen in this study. Three percent of patients receiving Intuniv® plus a stimulant discontinued from the study due to adverse events, compared to 1 percent in the placebo plus stimulant group.
Is
general: Yes
