By COLLEEN CREAMER
For VerusMed
The Food and Drug Administration has approved a labeling change for Novartis Pharmaceuticals Corp.’s Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD) that demonstrates the drug’s efficacy 30 minutes after dosing.
The new prescribing information was supported by data from a double-blind crossover study that included 86 children aged 6 to 12 years with ADHD who were randomized to receive Focalin XR 20 mg or placebo for seven days. The final dose was administrated in a laboratory classroom setting on the last day of each treatment period.
The study’s primary efficacy endpoint was the change from predosing to 0.5 hour after dosing in the Swanson, Kotkin, Agler, Mylnn and Pelham (SKAMP) Rating Scale-Combined score, with additional secondary assessments at one, two, four, six and eight hours after dosing. The SKAMP rating scale specifically measures the classroom manifestation of ADHD.
Results showed that Focalin XR provided significant improvements at 30 minutes after dosing as compared with placebo in measures of attention, deportment and academic productivity.
“The 30-minute onset of action can help children with ADHD improve their morning academic productivity in school,” said Dr. Rafael Muniz, senior medical director at Novartis Pharmaceuticals. “Focalin XR also allows them to effectively manage their symptoms for up to 12 hours, getting them through school and homework time.”
The drug is indicated for the treatment of ADHD in patients aged 6 years or older.
–From VerusMed.com
