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2-Nov-2009

New Higher Dose of Focalin XR® Improves Control of ADHD Symptoms for Up to 12 Hours

• FDA approval of Focalin XR 30-mg strength gives physicians an additional treatment option and greater dosing flexibility for individuals with ADHD
• New clinical data evaluating the safety and efficacy of Focalin XR 30 mg versus 20 mg in children with ADHD presented at AACAP
• Symptoms of ADHD can significantly impact a person's ability to focus, work and behave in school

East Hanover, NJ, November 2, 2009 - The US Food and Drug Administration (FDA) has approved a higher 30-mg dose of Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The new strength provides physicians with an additional treatment option that offers statistically significant improvement in ADHD symptoms for up to 12 hours compared with the placebo.

"The 30-mg dose of Focalin XR helps address an unmet need for patients seeking a long-acting prescription medication that helps control ADHD symptoms later in the day," said Matthew Brams, MD, Clinical Assistant Professor, Menninger Department of Psychiatry, Baylor College of Medicine. "The approval of this new strength will provide physicians with confidence when making the choice to prescribe a higher dosage of an ADHD prescription medication."

ADHD affects about three to seven percent of school-aged children, and between two to four percent of adults in the United States. Its symptoms - inattention, hyperactivity and impulsivity - can significantly influence a person's ability to focus and behave in school.  For many people with this disorder, ADHD medications reduce hyperactivity and impulsivity, and improve their ability to work and pay attention.

Details of Clinical Data Supporting FDA Approval

A Clinical Overview summarizing the safety and efficacy of Focalin XR at doses of 30 mg/day in children and 30 mg/day and 40 mg/day in adults supported the approval of the new increased dose formulation of Focalin XR.  The summary of clinical safety and efficacy data submitted to the FDA included four pediatric studies, one adult study and two studies with healthy volunteers.  Overall, the data demonstrated that Focalin XR is efficacious at doses of 30 mg/day in children, and 30 mg/day and 40 mg/day in adults compared with placebo.  Adverse events (AEs) and discontinuations were dose-related.

New Data Presented at the American Academy of Child and Adolescent Psychiatry (AACAP)

In addition, new data evaluating the safety and efficacy of Focalin XR 30 mg versus 20 mg in children with ADHD were presented at AACAP on October 30, 2009.

Results of the randomized, double-blind, crossover study involving 165 children with ADHD between the ages of 6 and 12, demonstrate Focalin XR 30 mg provides significantly greater improvement in ADHD symptoms compared with the 20-mg dose, including benefits to patients who do not maintain adequate symptom control later in the day with the smaller dose.

The study compared changes in the average Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale-Combined score from pre-dose to 10, 11, and 12 hours post-dose. In addition, researchers monitored average change from pre-dose in SKAMP-Deportment and Attention and Math test scores. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior. 

Overall, adverse events (AEs) rates were 28.2% (30 mg), 21.6% (20 mg) and 17.6% in the placebo group. The most common AEs (=3% in any group) were decreased appetite, headache, abdominal pain, and tachycardia (increased heart rate).

FOCALIN XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. FOCALIN XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

The effectiveness of FOCALIN XR for long-term use, ie, more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use FOCALIN XR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Important Safety Information

WARNING: DRUG DEPENDENCE FOCALIN XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

FOCALIN XR is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms; in patients known to be hypersensitive to methylphenidate or other components of the product; in patients with glaucoma; in patients with motor tics or with a family history or diagnosis of Tourette syndrome; and during or within a minimum of 14 days following discontinuation of treatment with monoamine oxidase inhibitors (MAOIs), as hypertensive crisis may occur.

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Increased blood pressure and heart rate have been reported in patients taking FOCALIN XR. Patients should be assessed for preexisting cardiac conditions before starting FOCALIN XR.

Psychotic symptoms may be exacerbated in patients with psychotic disorders. Use with caution in patients with comorbid bipolar disorder. Treatment-emergent new psychotic or manic symptoms may occur without a prior history. Monitor for appearance or worsening of aggressive behavior or hostility.

Long-term suppression of growth has been reported with long-term use of stimulants. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The threshold for seizures may be lowered. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Periodic monitoring of CBC with differential is advised during prolonged therapy.

The most common adverse events (at least 5% and twice the incidence of placebo-treated patients) are dyspepsia, decreased appetite, headache, and anxiety for pediatric patients, and dry mouth, dyspepsia, headache, and anxiety for adult patients.

Please see full Prescribing Information for Focalin XR, including a Medication Guide, at www.FocalinXR.com or call us at
1-888-NOW-NOVA.

For further information, please visit www.FocalinXR.com.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "option," "can," "will," or similar expressions, or by express or implied discussions regarding potential additional labeling or indications or potential future sales of Focalin XR. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will be approved for any additional labeling or indications in any country. Nor can there be any guarantee that Focalin XR will reach any particular sales levels. In particular, management's expectations regarding Focalin XR could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data, and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis Partnerships
Celgene Corporation (Nasdaq: CELG) of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin XR in the U.S.

Focalin XR was developed with SODAS® technology (spheroidal oral drug absorption system), a multiparticulate drug delivery system of Elan Corporation, plc (NYSE: ELN). Focalin XR is being supplied to Novartis under an exclusive worldwide (except Canada) royalty and manufacturing agreement between Elan Corporation, plc, and Novartis Pharma AG.

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Michael Billings Novartis Pharmaceutical Corporation 862-778-8656 (office) 201-400-1854 (cell) michael.billings@novartis.com

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