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Focalin XR Receives FDA Approval of New Labeling Information in Attention-Deficit/Hyperactivity Disorder

Extended-release ADHD treatment has rapid onset of action and positive treatment effect for up to 12 hours

EAST HANOVER, N.J. -- May 23, 2006 -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for its Attention-Deficit/Hyperactivity Disorder (ADHD) medication Focalin XR(TM) (dexmethylphenidate HCl) extended-release capsules, which describes studies showing that Focalin XR works fast and is effective for up to 12 hours. Focalin XR is indicated for the treatment of ADHD in adults, adolescents and children.

The new information in the labeling (package insert) is based on two additional studies in pediatric patients ages 6-12 showing statistically significant improvements in ADHD symptoms of attention and behavior versus placebo at every hour up to and including 12 hours after administration. In each of these crossover studies, patients received a single dose of 20 mg Focalin XR or placebo.

Both studies demonstrated that Focalin XR was significantly more effective than placebo in treating ADHD symptoms, as measured by the Swanson, Kotkin, Agler, Mylnn and Pelham (SKAMP) rating scale, at each time point measured. The SKAMP rating scale evaluates attention and behavior in clinical trials.

"It's important for physicians and their patients to know that their ADHD medication will have a rapid onset of action and continue working throughout their school or work day and beyond," said Rafael Muniz, Medical Director, Neuroscience, Novartis Pharmaceuticals Corporation. "With this update to the label, physicians and patients can be confident that Focalin XR is a treatment that will meet these needs."

In adults and children, the core symptoms of ADHD are inattention, impulsivity and hyperactivity; however, in adults symptoms of hyperactivity often subside with maturity or may manifest differently. ADHD is one of the most common psychiatric disorders of childhood and is estimated to affect 5% to 7% of children. Many children with ADHD will continue to experience symptoms into adulthood. ADHD is estimated to affect approximately 4% of the adult population.

Focalin XR was generally well tolerated. There were no significant changes in patient weight or vital signs, such as sitting pulse or sitting blood pressure, in adults or children. The most common side effects in adults and children include decreased appetite, headache, dyspepsia, anxiety, insomnia, feeling jittery and anorexia.

The approval of Focalin XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD.

About Focalin XR
Focalin XR is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged six years and older, adolescents and adults. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (e.g., psychological, educational, social) for patients with this syndrome.

Focalin XR is an extended-release form of Focalin(TM) (dexmethylphenidate HCl). Focalin is an advance in single-isomer technology and is formulated by isolating the active d-isomer of methylphenidate. Data suggest that the d-isomer is responsible for the effective management of the symptoms of ADHD. Focalin XR is available in 5, 10 and 20 mg capsules for oral administration.

Like most drugs approved for the treatment of ADHD, Focalin XR is contraindicated in patients known to be hypersensitive to the drug or to methylphenidate, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome. It is also contraindicated during treatment with monoamine oxidase inhibitors and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). Focalin XR should generally not be used in those who have structural cardiac abnormalities. In addition, like most drugs approved for the treatment of ADHD, Focalin XR is a schedule II drug and should be given cautiously to patients with a history of drug dependence or alcoholism.

For further information about Focalin XR, visit http://www.FocalinXR.com.

About ADHD
ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior, and sustain focus in developmentally appropriate ways. In adults, it is associated with poor functioning in educational and occupational environments, as well as emotional, social and economic problems. For further information, visit http://www.ADHDInfo.com.


SOURCE: Novartis Pharmaceuticals Corporation

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