Schizophrenia Daily News Blog

Lower Dose of Injectable Risperdal Gets Approved

The U.S. Food and Drug Administration (FDA) has approved a new, lower dose -- 12.5 mg -- of Risperdal Consta (risperidone) Long-Acting Injection for the treatment of schizophrenia within specific patient populations. Patients who may need this lower dosage may include those with renal (kidney) or hepatic (liver) problems, and those who need lower doses due to side-effects. Risperdal Consta is manufactured by Alkermes, Inc. and marketed in the U.S. by Janssen, L.P.

"The 12.5 mg dose of Risperdal Consta will help clinicians to customize treatment for each patient, particularly those who have hepatic or renal impairment and need lower doses," said Henry Nasrallah, M.D., Professor of Psychiatry and Neuroscience, and Director of the Schizophrenia Research Program at the University of Cincinnati. "In addition, this smaller dose will be relevant for patients who may be at risk for drug-drug interactions which could increase the plasma concentrations of Risperdal Consta , or in patients who have a history of low tolerability to the usual starting doses of psychotropic medications."

The new dose of Risperdal Consta, which is expected to be available by May 1, is the lowest formulation of the long-acting injection. Risperdal Consta is also available in 25 mg, 37.5 mg and 50 mg dose units. The FDA approval of the 12.5 mg dose was based on pharmacokinetic data in schizophrenia patients that demonstrated an expected profile for the lower dosage strength. The efficacy of the 12.5 mg dose has not been investigated in clinical trials.

Risperdal Consta was approved for the treatment of schizophrenia in the U.S. in 2003.

Using proprietary Medisorb drug-delivery technology developed by Alkermes, the Risperdal Consta formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water- based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.

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