Shire announced an FDA approval for Intuniv (guanfacine) Extended Release Tablets yesterday, and is preparing professional advertising efforts for a November launch.

Matthew Cabrey, a spokesperson for Shire, said the company is launching a “significant initiative” with physicians, to help them “understand the unique characteristics” of the ADHD product. A comprehensive patient support program will launch in November as well, with a larger consumer effort to launch in 2010 ( site here). 

Consumer and professional work for Intuniv is handled by CDM’s Princeton, NJ office. Porter Novelli has the PR assignment on the brand.

On the professional side, Cabrey said Shire’s ADHD team, consisting of 600 reps, would promote Intuniv along with Vyvanse and Daytrana, all of which have indications for children. GlaxoSmithKline co-promotes Vyvanse with Shire for adult populations, but will not be involved with Intuniv promotions. Intuniv is indicated for children ages 6-17, while Vyvanse and Daytrana are indicated for children ages 6-12.

“There is a strategy for the promotion of Intuniv,” said Cabrey. “There will be some opportunities where Intuniv will be promoted in the number one slot [with pediatricians], and others where Vyvanse will be number one with Intuniv at number two, depending on geography and target audience” or other factors, he said.

Guanfacine, the active ingredient in Intuniv, has been marketed in an immediate release form by other manufacturers, such as Promius Pharma’s Tenex. The mechanism of action for guanfacine is unknown. Shire received an approvable letter for Intuniv in June 2007, and then a complete response letter in August, before gaining final approval.

Colleen Zester, SVP, managing supervisor at CDM, addressed a consumer ad for Intuniv found via Google Video search on a photography gallery site for Robert Bacall Representatives and featuring creative apparently developed for the brand by Ferguson. “We’ve contacted the client about having the ad removed from the site,” Zester said, adding that copy and other creative elements in the ad were “troubling,” given the specific indication for Intuniv. CDM’s consumer creative will be “closely aligned” with professional creative. “The consumer campaign will take its lead from the professional materials,” said Zester.