SHIRE SUBMITS NDA FOR EXTENDED-RELEASE ADHD DRUG

Shire has submitted a new drug application (NDA) to the FDA for its investigational compound guanfacine extended release, which, if approved, would be the first once-daily selective alpha-2A-adrenoceptor agonist for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children ages 6 to 17. The application is subject to a 10-month FDA review period.

Shire has proposed the trade name Connexyn. The company plans to continue development of the drug by initiating a Phase IIIb clinical trial to assess its safety and efficacy in children with ADHD who also exhibit oppositional behavior.