Shire receives FDA response regarding Intuniv Extended Release

Shire has received a complete response letter from the Food and Drug Administration (FDA) regarding Intuniv (guanfacine) Extended Release.

In a statement, the pharmaceutical company noted that the regulator did not identify any safety concerns about the therapy, which is being studied for the treatment of ADHD in children between the ages of six and 17.

Additionally, it did not call for any new clinical studies to be carried out.

Shire said that it will now work with the FDA to create an appropriate label for the therapy over the next four to eight weeks.

Commenting, Mike Cola, president of Shire, stated that the firm – which is due to announce its second quarter earnings on August 5th – is “confident” that it will be able to launch the product in the fourth quarter of 2009.

“When approved, Intuniv will be the first selective alpha-2A receptor agonist for the treatment of ADHD and will provide patients with an important new treatment option,” he added.