FDA Issues Approvable Letter For Paliperidone ER For The Treatment Of Schizophrenia

Main Category: Schizophrenia
Article Date: 30 Sep 2006 - 0:00 PDT

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Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia.

Recognizing the importance of new treatment options in mental illness, JJPRD is evaluating the FDA letter and will work quickly to resolve the agency's questions in order to expedite approval of paliperidone ER.

JJPRD submitted a new drug application to the U.S. Food and Drug Administration in November 2005. Upon approval by U.S. regulatory authorities, paliperidone ER, a new chemical entity, will be marketed in the United States by Janssen, L.P.

Janssen, L.P., based in Titusville, N.J., is the only large pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia and bipolar mania. Concurrently, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities in May 2006 seeking approval to market the medication. The paliperidone ER submissions are based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries.

Paliperidone ER uses the OROS extended-release technology developed by ALZA Corporation. This technology provides a consistent release of medication over a 24-hour period leading to smooth blood plasma levels. ALZA, Janssen and JJPRD are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.

A global leader in pharmaceutical research and development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is a subsidiary of Johnson & Johnson and is committed to bringing to market high-value, cost-effective products that treat disease and significantly improve the health and lifestyles of people worldwide.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. Symptoms of schizophrenia are marked by hallucinations, delusions, depression, blunted emotions, social withdrawal and disorganized thinking.

For more information about Janssen, L.P., visit
http://www.janssen.com.

(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 Annual Report on Form 10-K for the fiscal year ended January 1, 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.)

Johnson & Johnson Pharmaceutical Research & Development
http://www.janssen.com

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