Guanfacine extended release: Phase III data

A double-blind U.S. Phase III trial in 455 patients ages 6-17 showed that up to 4 mg once-daily Intuniv in the morning or evening plus long-acting oral stimulants met the primary endpoint of significantly improving ADHD-RS-IV total score from baseline vs. placebo (20.3 and 20.9 vs. 16-point reductions, p=0.002 and p<0.001, respectively). There were no treatment-related serious adverse events.

Intuniv is approved in the U.S. to treat ADHD in children and adolescents ages 6-17. Last month, Shire submitted an sNDA to FDA for Intuniv as an adjunctive treatment co-administered with stimulants to treat ADHD in children and adolescents ages 6-17. ...