Shire's Intuniv improves ADHD upto 24hrs post dose

UK drugmaker Shire's Intuniv (guanfacine) extended-release tablets, a non-stimulant selective alpha-2A-receptor agonist, showed significant efficacy in reducing attention-deficit hyperactivity disorder symptoms for those taking the medication when compared to those given placebo at all measured time points up to 24 hours post-dose. The findings were presented t the American Psychiatric Association's annual meeting in Washington DC.

The US Food and Drug Administration issued an "approvable letter" on the drug last year (Marketletter July 2, 2007). Shire is conducting additional clinical work which is designed to enhance the label. Upon approval, the agent will be the first selective alpha-2A receptor agonist indicated for the treatment of ADHD that may provide an important treatment option for patients and physicians, the firm noted.

The pooled analysis evaluated results from these patients on a weight adjusted mg/kg basis from two similarly-designed, randomized, double-blind, forced-dose titration, multicenter Phase III trials. The primary efficacy measure for both studies was change in the ADHD Rating Scale total score from baseline to endpoint. All patient groups treated with Intuniv showed significantly greater improvement in ADHD-RS-IV total score from baseline to endpoint than the placebo group (p<0.001).