Shire plc, the global specialty biopharmaceutical company, announced results from a phase-3b study that found Vyvanse (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder (ADHD). Vyvanse is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these data were presented at the 49th annual New Clinical Drug Evaluation Unit meeting in Hollywood, FL. Vyvanse is currently approved by the US Food and Drug Administration (FDA) for the treatment of ADHD in children age six to 12 years and in adults with ADHD.
"Long-acting medication may be important for adults with ADHD because ADHD symptoms, such as inattention, hyperactivity, and impulsivity, may impact them at work, as well as in at least one other area of their life," said Matthew Brams, study author and psychiatrist in private practice with Bayou City Research, Ltd in Houston. "In this study, adults taking Vyvanse demonstrated significant efficacy as measured by the Permanent Product Measure of Performance (PERMP), from two hours, the first time point measured, up to 14 hours following administration. Additionally, adults taking Vyvanse demonstrated significant ADHD symptom improvement, as measured by the ADHD Rating Scale (ADHD-RS) with adult prompts. These findings may be important for adults who require ADHD symptom management at work, at home, and in social settings."
In this study, investigators evaluated adults with ADHD in an adult simulated workplace environment setting. In this setting, adults engaged in tests and activities that require a level of attention needed in many workplace settings. The efficacy of Vyvanse was measured by PERMP, a validated, time sensitive, skill adjusted math test designed to evaluate an adult's ability to attend, initiate, and complete written seatwork. The PERMP was administered at intervals during the course of the simulated workplace environment day.
"This study provides important information for physicians about the effect of treatment with Vyvanse throughout the day in adults," said Michael Yasick, senior vice president of the ADHD Business Unit at Shire. "Shire is committed to providing effective treatments for adults with ADHD who need significant symptom improvement through the day and into the evening. We are proud to have evaluated Vyvanse in adults in this workplace-like environment."
The adult simulated workplace environment study supports the results of a previous phase-3 clinical trial in adults in which once-daily Vyvanse significantly improved ADHD symptoms of inattention, such as the ability to focus and organize, as well as hyperactivity and impulsivity. In this previous study, the most common adverse events (greater than or equal to 5 per cent and twice placebo) were decreased appetite, dry mouth, insomnia, nausea, diarrhoea, anxiety, and anorexia.