FDA approves new Risperdal Consta dose

The US Food and Drug Administration has approved a 12.5mg dose of Risperdal Consta (risperidone) long-acting injection for the treatment of schizophrenia within specific patient populations, including those with renal and hepatic impairment. The new dose of the drug, which is sold by Johnson & Johnson subsidiary Janssen and manufactured by Alkermes, will provide physicians with more options to individualize treatment approaches and adjust therapies when clinical factors warrant dose changes, the companies note.

The 12.5mg 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, 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," he noted.

The drug was first approved for the treatment of schizophrenia in the USA in 2003.