Shire publishes new study results on INTUNIV Extended-Release Tablets

Porter NovelliNov 17 2009

Primary objective of the study was to evaluate the safety of coadministration of INTUNIV with stimulants

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using the ADHD Rating Scale-IV (ADHD-RS-IV). INTUNIV is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD in children and adolescents ages 6 to 17.

"Pivotal studies have shown that INTUNIV improved ADHD symptoms in children and adolescents with the disorder, and the publication of these safety data gives us insight into administering INTUNIV in combination with stimulant medications in the management of ADHD," said Andrew J Cutler, MD, courtesy assistant professor, department of psychiatry, University of Florida, and CEO and medical director, Florida Clinical Research Center, Bradenton, FL. "This study helped inform the design of a controlled coadministration trial of INTUNIV with stimulant medications, which Shire is currently conducting."

An estimated 25 to 30 percent of ADHD patients may not respond to the most commonly prescribed ADHD medications, methylphenidates and amphetamines, when used alone as ADHD treatment.