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.