FDA Grants Pediatric Exclusivity For RISPERDAL® (Risperidone)

Main Category: Autism
Also Included In: Bipolar;  Pediatrics / Children's Health;  Psychology / Psychiatry
Article Date: 12 Mar 2007 - 0:00 PDT

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The U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for RISPERDAL® (risperidone), based on studies conducted in Bipolar 1 Disorder and schizophrenia. The patent is set to expire in December 2007, however, this grant will extend the period of exclusivity on risperidone through June 2008.

RISPERDAL® is approved in the U.S. to treat acute manic or mixed episodes of Bipolar I Disorder and for the treatment of schizophrenia in adults. It is marketed by Janssen, L.P.

In October 2006, RISPERDAL® was also approved in the U.S. for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods, in children and adolescents ages five to 16 years. That indication was the first time the FDA approved any medication for use in children and adolescents with autism.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Important Safety Information

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

The most common side effects are sleepiness, increased appetite, fatigue, upper respiratory tract infection, increased saliva, constipation, dry mouth, tremor, muscle stiffness, dizziness, repetitive behavior, involuntary movement, rapid heartbeat, confusion and weight increase.

Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL®. Some people may need regular blood sugar testing.

You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you or your child observe these symptoms, talk to your health care professional.

A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL®, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.

Some people taking RISPERDAL® may feel faint or lightheaded when they stand up or sit up too quickly.

You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors and muscle stiffness. If you or your child observe these symptoms, talk to your health care professional.

Some medications interact with RISPERDAL®. Please inform your health care professional of any medications or supplements that you are taking. Avoid alcohol containing products while on RISPERDAL®.

Inform your health care professional if you are already pregnant or if you are planning to get pregnant while taking RISPERDAL®. Do not breast-feed if you are taking RISPERDAL®.

RISPERDAL® may affect alertness and motor skills; use caution until the effect of RISPERDAL® is known.

Keep out of reach of children.

Approved for marketing in more than 100 countries, RISPERDAL® is the most widely prescribed atypical antipsychotic in the world. Janssen , L.P., has marketed RISPERDAL® in the United States since 1994. It is given as an oral tablet, a quick-dissolve tablet or an oral solution. For more information, visit http://www.risperdal.com.

Based in Titusville, NJ, Janssen, L.P., currently markets prescription medications for the treatment of schizophrenia, bipolar disorder and for the treatment of irritability associated with autistic disorder. For more information, visit http://www.janssen.com.

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