Efficacy in Adults

An effective workday treatment*

Focalin® XR (dexmethylphenidate hydrochloride) extended-release capsules demonstrated significant improvements in DSM-IV ADHD rating scale total scores.

	Adapted from Data on file.1 The change from baseline versus placebo in the DSM-IV rating scale total score was the primary efficacy outcomes measure in this trial.

Study design: A 5-week, randomized, double-blind, placebo-controlled trial of Focalin® XR in adults with Attention Deficit Hyperactivity Disorder (ADHD). Patients were randomized to receive either 20 mg, 30 mg, or 40 mg of Focalin® XR (n=168) or placebo (n=53) once daily for 5 weeks. Patients were initially given 10 mg of Focalin® XR and titrated upward in increments of 10 mg/week. At the end of 5 weeks, patients had the option to continue on a flexible dose of Focalin® XR in an open-label extension for a total of 29 weeks. Baseline demographics were comparable between the 2 groups.¹

• Statistically significantly greater change from baseline in the DSM-IV ADHD rating scale total score than placebo (P=.006)¹
• Improvement in scores should be attributed to an improvement in attention and concentration

A strong focus

Focalin® XR (dexmethylphenidate hydrochloride) extended-release capsules demonstrated significant improvements in attention in adult ADHD patients.

	Adapted from Data on file.1

• Statistically significantly greater change from baseline in the DSM-IV ADHD rating scale inattention subscale score than placebo (P=.021)¹
• In addition, statistically significantly greater change from baseline in the DSM-IV ADHD rating scale hyperactive-impulsive subscale score was seen versus placebo (6.0 versus 3.2, P=.005)¹
• The changes from baseline versus placebo in the DSM-IV ADHD rating scale inattention subscale and hyperactive-impulsive scores were secondary efficacy outcomes measures in this trial¹

*Versus untreated placebo patients

REFERENCE:

1. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.