Shire submits Connexyn NDA to US FDA

3 September 2006

UK drugmaker Shire has submitted a New Drug Application to the US Food and Drug Administration for its investigational compound guanfacine (SPD503 extended-release) which, if approved, would be the first once-daily selective alpha-2A-adrenoceptor agonist for the treatment of attention-deficit hyperactivity disorder in children aged six to 17 years. Shire has proposed the trade name Connexyn for the product, noting that the application is subject to a 10-month FDA review period.

Matthew Emmens, Shire's chief executive, hopes that, as the first selective alpha-2A-adrenoceptor agonist submitted to the FDA for the treatment of ADHD, Connexyn could "enhance [Shire's] product portfolio as a new non-stimulant ADHD medication."

The Basingstoke-headquartered firm 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.

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