Shire reports positive clinical trial data for ADHD drug

Shire has announced positive data from a phase III clinical trial of guanfacine hydrochloride extended release (GXR), its new therapy for attention deficit hyperactivity disorder (ADHD).

The placebo-controlled study assessed the efficacy and safety of once-daily dose-optimised GXR in the treatment of children and adolescents aged six to 17 years with moderate-to-severe symptoms of ADHD.

It was found that patients experienced a significant reduction in ADHD core symptoms and global functioning in children and adolescents living with the disorder when treated with GXR, while its safety profile was also confirmed.

Shire submitted a marketing authorisation application to the European Medicines Agency seeking approval of the drug in this indication in March 2014.

Tamara Kiechle, Shire's global medical lead for neuroscience, said: "Each individual's experience of ADHD is different, and Shire believes the individual needs of those living with ADHD must be considered, allowing for tailored therapy and appropriate management."

The drug is already available in the US under the brand name Intuniv and in Canada as Intuniv XR.