Shire plc, the global specialty biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse (lisdexamfetamine dimesylate) Capsules controlled substance (CII), to include supplemental data demonstrating significant improvement in attention in adults with ADHD.
With this, the company will include supplemental data demonstrating significant improvement in attention in adults with ADHD across all six assessments conducted at two, four, eight, 10, 12 and 14 hours after administration as measured by average Permanent Product Measure of Performance (PERMP) total scores, as well as at each time point measured. Vyvanse is now the first and only oral ADHD long-acting stimulant treatment to have efficacy data at 14 hours postdose for adult patients included in its product labelling.
“The availability of an ADHD treatment for adults that provides efficacy throughout the day and into the evening is important as adults may need to manage their symptoms beyond the work day,” said Michael Yasick, senior vice president of the ADHD Business Unit at Shire. “Shire is pleased with the US FDA approval of this labelling change for Vyvanse.”
The update to the Vyvanse product labelling is based on a 14-hour modified analog classroom study of Vyvanse to simulate a workplace environment in 142 adults who met DSM-IV-TR criteria for ADHD. The data support the results of a previous phase-3 clinical study of adults with ADHD in which Vyvanse significantly improved the ADHD symptoms of inattention (for example, lack of focus), as well as of hyperactivity and impulsivity, as measured by the ADHD Rating Scale (ADHD-RS-IV) with adult prompts, a standard validated tool. The most common treatment-emergent adverse events in patients taking Vyvanse in this previous study were decreased appetite, trouble sleeping, dry mouth, nausea, diarrhoea, anxiety and loss of appetite.
As with other stimulant medications, Vyvanse is classified as CII because of its potential for abuse.
Vyvanse, which was introduced in the US in July 2007 for the treatment of ADHD in children aged six to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.