Shire (NasdaqGS: SHPGY) Provides Update On ADHD Drug
Shire (
NasdaqGS: SHPGY) has an expected PDUFA decision date during 2H09 for its NDA resubmission to the FDA in late January 2009 for marketing approval of Intuniv (guanfacine extended release – a non-controlled drug that is already available in regular formulations on a generic basis, but is dosed multiple times per day on this basis) for the proposed treatment of attention deficit hyperactivity disorder (ADHD) in children.
If FDA approval is received, Shire expects to launch Intuniv in the U.S. during 4Q09.
Click here for more details on BioMedReports.com database of pending FDA decisions and clinical trial results, which are organized in a calendar format with over 200 entries.
On 5/18/09, Shire announced new clinical data on Intuniv in children aged 6-12 years with a diagnosis of ADHD and the presence of oppositional symptoms.
In this randomized, placebo-controlled, flexible-dose study, Intuniv demonstrated significant ADHD symptom improvement in patients with oppositional symptoms as measured by the ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials.
Intuniv is currently being studied as a once-daily, extended release formulation of guanfacine designed to provide steady delivery of drug throughout the day.
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