Shire’s Once-Daily ADHD Tablets Approved in Europe

Shire announced that the European Commission has approved its once-daily, non-stimulant Intuniv (guanfacine hydrochloride prolonged-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated, or have been shown to be ineffective. Approval was granted based on results from three pivotal Phase III trials investigating the safety and efficacy of Intuniv in children and adolescents with ADHD.

Intuniv is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe. According to Shire, Intuniv must be used as a part of a comprehensive ADHD treatment program, which typically includes psychological, educational, and social measures.

Perry Sternberg, senior vice-president, Neuroscience Business Unit, Shire, said in a press statement that the approval of Intuniv is a significant milestone in the treatment of ADHD in children and adolescents in Europe, given that previously there was only one licensed non-stimulant option available. “The importance of simply providing physicians with the ability to choose the non-stimulant option that may best suit the needs of their patients should not be overlooked, considering the complexities and different manifestations of the disorder in children and adolescents,” Sternberg said.