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Investigational Data Presented for INTUNIV™ (guanfacine) Extended-Release Tablets When Coadministered With Stimulants Showed ADHD Symptom Improvement in Overall, Morning and Evening Assessments
Date:10/28/2010

NEW YORK, Oct. 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV™ (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.  At study end point, patients receiving INTUNIV coadministered with a stimulant had significantly reduced symptoms on the ADHD Rating Scale IV (ADHD-RS-IV) compared with those receiving placebo with a stimulant, regardless of morning or evening dosing.  These data were presented in a poster session at a major national scientific meeting of psychiatry in New York, NY.

"This study looked at patients who were taking a stable dose of a long-acting stimulant medicine but who continued to experience ADHD symptoms," said Timothy Wilens, MD, Staff in the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School, who led the study.  "These findings provide greater insight into the use of INTUNIV when combined with a stimulant."

INTUNIV is a selective alpha-2A agonist approved for the treatment of ADHD in children and adolescents ages 6 to 17.  Efficacy was based on two pivotal studies (8 and 9 weeks in duration) of INTUNIV administered as monotherapy.  INTUNIV is indicated as an integral part of a total treatment program that may include counseling or other measures.

These data presented today were included as part of a supplemental New Drug Application (sNDA) submitted to the Food and Drug Administration (FDA) on April 28, 2010, seeking approval for INTUNIV as an ADHD
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