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FDA Approves New Molecular Entity for Schizophrenia

Paliperidone is a metabolite of risperidone that is superior to placebo for treatment

WEDNESDAY, Dec. 20 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug, called Invega (paliperidone), for the treatment of schizophrenia. The drug, an atypical antipsychotic, is a metabolite of risperidone but is considered a new molecular entity as it has never been approved or marketed in the United States before.

The drug will be made by the ALZA Corp. in Mountain View, Calif., for Janssen, which is based in Titusville, N.J. Side effects include restlessness, extrapyrimidal symptoms, rapid heartbeat and sleepiness. The drug is not approved for dementia-related psychosis in elderly patients because atypical antipsychotics have been found to increase the mortality risk in such patients.

The drug's recommended dose is 3 mg to 12 mg per day and it has not been evaluated beyond six weeks of therapy in a placebo-controlled trial. Patients who take the drug for longer periods of time need to be periodically re-evaluated by their physician.

"Schizophrenia can be a devastating illness requiring life-long medication and professional counseling," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research, in a statement. "Today's approval adds to the treatment options for patients with this condition."

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