Paliperidone is an atypical antipsychotic developed by Janssen Pharmaceuticals. It is an extended release formula using the OROS extended release system, which allows it to be delivered to the patient for a 24-hour duration. It is the 9-hydroxy offshoot of risperidone.

This agent will basically be marketed for the treatment of schizophrenia and then for the bipolar mania. Clinical trials of Paliperidone for the treatment of schizoaffective disorder are also being planned. Paliperidone ER uses the patented OROS technology, which releases the 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 decided.

The Paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in over 23 countries. Regulatory submissions are expected to be followed for Paliperidone ER in other countries as well.

Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, social withdrawal, delusions and a diminished capacity for organized thought. Paliperidone extended-release tablets, an investigational, once-daily oral medication for schizophrenia, significantly improved sleep onset, sleep continuity, and duration of sleep in schizophrenia patients diagnosed with schizophrenia-related insomnia when compared with placebo. The data from this study was presented at the 19th Congress of the European College of Neuropsychopharmacology. This study was a multi-center, double blind, and randomized, placebo- controlled study of 36 patients with schizophrenia-related insomnia conducted at eight centers in Europe.