Shire Announces Study Results Of The Effects Of INTUNIV™ Extended Release On Secondary Measures In Children With ADHD And Oppositional Symptoms

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced new findings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo controlled trial met its primary objective, which was to evaluate the effects of INTUNIV on oppositional symptoms in children aged 6 to 12 years with a diagnosis of ADHD and the presence of oppositional symptoms. The data presented today on this investigational compound reviewed secondary efficacy measures from three different rating scales.



"A significant number of pediatric ADHD patients present with behaviors such as anger, resentfulness, defiance, and arguing with adults. It can be complicated for physicians and caregivers to find the right medication to control symptoms for children with ADHD exhibiting these behaviors," said Daniel Connor, MD, professor and division chief of child and adolescent psychiatry at the University of Connecticut Medical School. "When considered with the primary efficacy results of the current study, these data provide additional support for the clinical efficacy of INTUNIV for treating ADHD in this patient population."




On January 26, 2009, Shire filed a resubmission to the US Food and Drug Administration (FDA) of the New Drug Application to support approval for the treatment of ADHD in children and adolescents. Once available, INTUNIV will be the first selective alpha-2A receptor agonist approved for the treatment of ADHD.




INTUNIV Demonstrated Significant Efficacy in Secondary Endpoints


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. In results from this study presented today, INTUNIV also demonstrated symptom improvement as measured by three different rating scales: the Clinical Global Impressions-Improvement (CGI-I), the Conduct Problem Subscale of the New York Parent Rating Scale-School-Aged (NYPRS-S), and the Parent Stress Index-Short Form (PSI/SF) questionnaire.



When using the CGI-I scale, investigators rated 7 out of 10 patients as "very much improved" or "much improved" compared with placebo (71.5 percent vs 32.0 percent; P