WEDNESDAY, Dec. 20, 2006 (HealthDay News) -- Extended-release Invega (paliperidone) tablets have been approved for treatment of schizophrenia, the U.S Food and Drug Administration announced Wednesday.
The approval is based on the findings of three, six-week trials conducted in North America, Europe and Asia that included a total of 1,665 patients. The studies found that the drug was more effective than placebo at relieving symptoms of schizophrenia.
In the trials, the patients were given doses ranging from 3 milligrams to 15 mg a day. The recommended dose range for Invega is 3 mg to 12 mg. a day, the FDA said.
Side effects that were commonly reported by patients in the studies included restlessness, movement disorders, rapid heart beat and sleepiness.
Since the effectiveness of Invega has not been evaluated for longer than six weeks, patients taking the drug for extended periods should be periodically reevaluated by a doctor, the FDA said.
Invega belongs to a class of drugs called atypical antipsychotics. Compared to placebo, these drugs are associated with an increased death rate among elderly patients with dementia-related psychosis. Invega is not approved for treating dementia-related psychosis, the FDA said.
To learn more about schizophrenia, visit the National Institute of Mental Health.