Shire files NDA for attention-deficit drug guanfacine

By Elaine Rigoli

Tampa, Fla., Aug. 24 - Shire plc said it submitted a New Drug Application to the Food and Drug Administration for its investigational compound guanfacine extended release (previously referred to as SPD503) to treat attention deficit hyperactivity disorder in children aged six to 17 years.

Shire said it has proposed the trade name Connexym for the product.

The application is subject to a 10-month FDA review period.

Shire plans to continue development of guanfacine extended release by beginning a phase 3b clinical trial to assess its safety and efficacy in children with ADHD.

"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," chief executive officer Matthew Emmens said in a news release.

Shire is a London-based pharmaceutical company.

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