If approved, guanfacine extended release (previously referred to as SPD503) would be the first once-daily selective alpha-2A-adrenoceptor agonist for the treatment of ADHD in children aged six to 17 years. The application for guanfacine extended release, for which Shire has proposed the trade name Connexyn, is subject to a 10-month FDA review period.
Shire is seeking approval of 1, 2, 2.5, 3, 3.5 and 4mg once-daily guanfacine extended release doses for the control of ADHD symptoms throughout the day in children aged six to 17 years. The new drug application includes data from two placebo-controlled trials in children and adolescents ages six to 17 evaluating the compound’s safety and efficacy in controlling ADHD symptoms evaluated on a once-weekly basis using the ADHD Rating Scale-IV, which included both hyperactive/impulsive and inattentive subscales.
Shire plans to continue development of guanfacine extended release by initiating a phase IIIb clinical trial to assess its safety and efficacy in children with ADHD who also exhibit oppositional behavior.
“As the first selective alpha-2A-adrenoceptor agonist submitted to the FDA for the treatment of ADHD, Connexyn, if approved, would enhance our product portfolio as a new non-stimulant ADHD medicationm,” commented Matthew Emmens, Shire’s CEO. “With this submission, as well as the recent approval and launch of Daytrana, the regulatory submission of SPD465, and the anticipated FDA response this October concerning NRP104, we have been successful in advancing our ADHD pipeline considerably.”