ROCKVILLE, Md. -- The FDA today approved Invega (paliperidone) for treatment of acute schizophrenia.
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.
Since Invega efficacy has not been evaluated in placebo-controlled trials for longer than six weeks, the FDA said physicians should periodically reevaluate patients who use the drug for extended periods.
The FDA cautioned that Invega belongs to the atypical antipsychotic class, and, compared with placebo, atypical antipsychotic drugs have been associated with an increased risk of death of in elderly patients with dementia-related psychosis.
The FDA added that Invega "is not approved for dementia-related psychosis."
In clinical trials. commonly reported adverse events were restlessness, extrapyramidal symptoms, rapid heartbeat and sleepiness.
Invega is manufactured by Alza in Mountain View, Calif., for Janssen, in Titusville, N.J.