PHILADELPHIA November 12, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years. The post hoc analysis showed that patients demonstrated an improvement in emotional lability composite CPRS-RS scores while taking Vyvanse as compared to placebo. These results were presented recently at a psychiatric meeting in Honolulu.
"Children taking ADHD medications can experience emotional lability, often described as frequent changes in emotions or mood. Therefore, evaluating the impact of ADHD treatments, including Vyvanse, on children's emotional lability may be important for parents and health care professionals when assessing a child's treatment plan," said Ann C. Childress, MD, study investigator and president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas.
About the Analysis and Study
This post hoc analysis was based on a Phase 3, randomized, double-blind, placebo-controlled trial with forced-dose escalation of Vyvanse (30, 50, or 70 mg/d) or placebo in 285 children aged 6 to 12 years with ADHD. The primary end point of the study was the ADHD-RS IV, and secondary end points included CPRS-RS and safety. The CPRS-RS scale in its entirety contains 27 items to evaluate children's behaviors based on parents' responses. Each of the CPRS-RS 27 items is scored from zero as "Not At All True/Never, Seldom" up to three as "Very Much True/Very Often, Very Frequent." Parents completed the CPRS at 10 AM, 2 PM, and 6 PM at study start and on the day before their children made the weekly study visits. In the post hoc analysis, the children's emotional lability score was determined based on the sum of their average scores from three items on the CPRS-RS: angry/resentful, loses temper, and irritable. Patients were then grouped into those with and without prominent emotional lability at study start (scores greater than three versus scores of three or less) so that each group could be evaluated separately.
Overall, the children's average emotional lability scores significantly improved with Vyvanse treatment compared with placebo across the day (10 AM, 2 PM, and 6 PM) from study start to end (all P≤.0004).
As expected, treatment with Vyvanse, compared to placebo, did not result in significant improvements in emotional lability scores from study start to end in those without prominent emotional lability prior to treatment. However, treatment with Vyvanse, compared to placebo, yielded significant improvements in the emotional lability scores of those children with prominent emotional lability (P<.0001).
The most common treatment-emergent adverse events reported in this study for patients taking Vyvanse were decreased appetite, insomnia, upper abdominal pain, headache, irritability, vomiting, weight decrease, nausea, dizziness, and dry mouth.
Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
Vyvanse is a therapeutically inactive prodrug stimulant, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.
|Contact: Matt Cabrey|