Paliperidone effective in schizophrenia

New Jersey, USA-based Janssen, a wholly-owned subsidiary of US health care major Johnson & Johnson, says that data from a Phase III trial of paliperidone extended-release tablets demonstrate the drug's maintenance of long-term symptom stability in schizophrenic patients.

The findings, which were presented at the biennial meeting of the Congress of the Collegium Internationale Neuro-Psychopharmacologicum, held in Chicago, USA, are derived from a randomized, double-blind, placebo-controlled, parallel-group study of the compound in 207 schizophrenic patients. The trial showed that treatment reduced the number of schizophrenic events by more than half in comparison with placebo (22% paliperidone versus 52% placebo). Adverse events included: psychosis (23% placebo, 7% paliperidone ER); insomnia which occurred to a comparable extent in both groups; and extrapyramidal symptoms, which affected 7% of the patients in the drug-treated cohort versus 3% of those given placebo.

Paliperidone ER was submitted to the US Food and Drug Administration in November 2005 and European regulatory authorities in May of this year (Marketletter May 15). If approved, the product will be marketed by Janssen in the USA and Janssen-Cilag, also owned by J&J, in the European Union.