Shire gains extended US approval ADHA drug for Intuniv; files response on Firazyr

Ireland headquartered specialty drugmaker Shire (LSE: SHP) has received US Food and Drug Administration approved the use of once-daily Intuniv (guanfacine) as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged six to 17 as part of a total treatment program.

The approval is based on results from a nine-week placebo-controlled study of Intuniv when given in combination with a stimulant, in children and adolescents with ADHD. The recently-launched product generated revenues of $166 million during 2010.

"This approval of Intuniv for treating ADHD as adjunctive therapy to a stimulant offers physicians a new treatment option for children and adolescents with ADHD who are having a suboptimal response to their current stimulant therapy," said Robert Findling, Director of Child and Adolescent Psychiatry at University Hospitals Case Medical Center and professor of Psychiatry and Pediatrics at Case Western Reserve University School of Medicine, a lead investigator for the study. “In this study, the once-daily dosing of Intuniv was effective when taken in the morning or the evening, giving physicians flexibility when it comes to treating their patients with ADHD,” he noted.