Intuniv guanfacine extended release: Additional Phase III data

Additional data from a 9-week, 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 secondary endpoints of significantly improving CGI-P scores from baseline when assessed in the morning (p=0.019 and p<0.001, respectively) and in the evening vs. placebo plus long-acting stimulants (p=0.002 and p<0.001, respectively). Additionally, Intuniv in the morning or evening plus long-acting stimulants significantly improved BSFQ scores from baseline vs. placebo plus long-acting stimulants (p<0.001 and p=0.002, respectively).

Shire previously reported that Intuniv plus long-acting oral stimulants met the primary endpoint of significantly improving ADHD-RS-IV total score from baseline vs. placebo (see BioCentury, May 31). Intuniv is approved in the U.S. to treat ADHD in children and adolescents ages 6-17. An sNDA for Intuniv as an adjunctive treatment co-administered with stimulants to treat ADHD in children and adolescents ages 6-17 is under FDA review with a Feb. 28, 2011, PDUFA date. ...