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FDA Grants Approval for Focalin XR (Dexmethylphenidate) for Treatment of Attention-Deficit Hyperactivity Disorder in Adults, Adolescents and Children

EAST HANOVER, NJ -- May 27, 2005 -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Focalin XR™ (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

"Focalin XR provides a new treatment option for adults, adolescents and children to address the many difficult symptoms of ADHD," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. "Focalin XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose."

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 five to seven percent of children. Many children with ADHD will continue to experience symptoms into adulthood. ADHD is estimated to affect approximately four percent of the adult population.

"We are pleased to introduce Focalin XR as a valuable treatment to help adults, adolescents and children effectively manage their symptoms of ADHD," said Paulo Costa, head of Pharma Americas and CEO, Novartis Pharmaceuticals Corporation. "Novartis has been a leader in helping ADHD patients since we first introduced Ritalin® in the 1960s. The addition of Focalin XR further emphasizes this commitment as it provides a new treatment option to address the many difficult symptoms of ADHD."

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.

Adult Study

A 5-week, double-blind, placebo-controlled study involving 221 men and women with ADHD aged 18 to 60, demonstrated Focalin XR to be safe and effective in treating ADHD symptoms in adults. Patients received Focalin XR or placebo once daily. Results indicated that Focalin XR was statistically superior to placebo, based on changes in the Diagnostic and Statistical Manual-IV (DSM-IV) ADHD Rating Scale, a standard assessment tool used in ADHD. Secondary measures included evaluations rated by patients, clinicians and observers.

Following the completion of the 5-week double-blind clinical trial, 170 patients continued into a 6-month open-label extension phase. Patients who switched from placebo to Focalin XR showed significant clinical improvement and patients continuing treatment with Focalin XR continued to show increasing benefits over six months, based on changes in the DSM-IV ADHD Rating Scale.

Focalin XR was generally well tolerated. The most frequently reported adverse events included headache, insomnia and decreased appetite.

Pediatric Studies

The efficacy and tolerability of Focalin XR for the treatment of ADHD in children was demonstrated in a pivotal clinical trial of children and adolescents aged 6 to 17 years diagnosed with ADHD.

In this trial, 103 ADHD patients aged 6 to 17 years received Focalin XR or placebo once daily for seven weeks. Results indicated that Focalin XR was statistically superior to placebo, based on the Conners' ADHD/DSM-IV Scales for Teachers (CADS-T). The CADS-T Rating Scale is a tool used in clinical trials to assess attention and behavior.

In an additional trial of 54 pediatric patients aged 6 to 12 years, investigators evaluated the efficacy of Focalin XR 20 mg/day at various points throughout the day. Focalin XR was found to be significantly more effective than placebo in treating ADHD symptoms after just one hour, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale. The SKAMP Rating Scale evaluates attention and behavior in clinical trials.

In these studies, Focalin XR was generally well tolerated. The most frequently reported adverse events included decreased appetite, headache, dyspepsia, upset stomach and anxiety.

About Focalin XR

Focalin XR is an extended-release form of Focalin™ (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). 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 www.FocalinXR.com <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 www.ADHDInfo.com <http://www.ADHDInfo.com>.


Source: Novartis Pharmaceuticals Corporation

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