ROCKVILLE, Md., Dec. 20 -- The FDA today approved Invega (paliperidone) for treatment of acute schizophrenia.
Although the drug contains an active substance never before approved by the FDA, that substance is an active metabolite of an old drug, the atypical antipsychotic Risperdal (risperidone), which is marketed for treating schizophrenia.
The effectiveness of Invega in the acute treatment of schizophrenia was established in three six-week placebo-controlled trials conducted in North America, Europe and Asia.
The 1,665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from 3 mg a day to 15 mg a day, Invega was superior to the placebo. The recommended dose range for Invega is 3 mg to 12 mg a day.