Pfizer announced that the Food and Drug Administration (FDA) has approved QuilliChew ER (methylphenidate HCl extended-release) chewable tablets for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 years.
QuilliChew ER was studied in a double-blind, randomized, placebo-controlled parallel group laboratory classroom study (n=90) that enrolled children aged 6–12 years with a diagnosis of ADHD based upon DSM-IV criteria. The primary and key secondary efficacy parameters were evaluated pre- and post-dose using the SKAMP Combined score during the classroom day at 0.75, 2, 4, 8, 10, 12, and 13 hours. Results showed that the average treatment effects for all time points was statistically significantly superior compared to placebo. Treatment with QuilliChew ER led to more improvements in attention and behavior with an onset at 45 minutes through 8-hour duration.
Pfizer also launched Quillivant XR (methylphenidate HCl extended-release) oral suspension in January 2013 for the treatment of ADHD in patients aged ≥6 years.
QuilliChew ER, a CII controlled substance, will be available as 20mg scored, 30mg scored, and 40mg unscored chewable tablets in 100-count bottles. It is expected to launch in the first quarter of 2016.
For more information call (800) 438-1985 or visit QuilliChewER.com.