Shire receives US FDA complete response letter for Intuniv
This article was originally published in Scrip
The US FDA has issued a complete response letter to Shire for its non-stimulant attention deficit hyperactivity disorder (ADHD) candidate Intuniv (guanfacine) extended release.
The letter is thought to address unresolved issues following Shire's labelling discussions with the agency.
Shire stressed that the FDA did not identify safety concerns regarding Intuniv or request additional clinical trials, adding that it was confident that the issues raised could be resolved quickly.
Intuniv agonises the alpha–2A receptors in the prefrontal cortex, which is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioural inhibition and enhance impulse control.
Addrenex Pharmaceuticals/Shionogi are also developing a alpha-2 adrenoceptor agonist for ADHD, Clonicel (clonidine SR). A US filing for this indication is expected this year.
Intuniv also received an approvable letter in 2007. At the time, the company did not disclose its contents.
If approved, it will add to Shire's ADHD portfolio, which includes its best-selling product Adderall XR (extended-release mixed amphetamine salts), the once-daily patch Daytrana (methylphenidate transdermal system) and Vyvanse (lisdexamfetamine dimesylate).