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news.Johnson & Johnson has submitted a new drug application to the FDA for paliperidone extended-release tablets, an investigational once daily, oral medication for the treatment of schizophrenia.
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Paliperidone ER uses OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. Upon FDA approval, the drug will be marketed in the US by Janssen LP, 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 two million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.