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New Drug Application Submitted for Paliperidone Extended-Release Tablets, Investigational Treatment for Schizophrenia
Paliperidone ER uses the patented OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. Paliperidone ER will be marketed in the United States by Janssen, L.P., a wholly owned subsidiary of Johnson & Johnson. The trade name for the marketed product has not yet been determined.
The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Regulatory submissions are expected to follow for paliperidone ER in other countries.
Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.
Source: Johnson & Johnson Pharmaceutical Research & Development