The USFDA has recently approved the new 12.5 mg dose of RISPERDAL® CONSTA® [(risperidone) Long-Acting Injection] for the treatment of schizophrenia within specific patient populations (including those with renal and hepatic impairment).
Manufactured by Alkermes, Inc. (Nasdaq: ALKS) RISPERDAL® CONSTA® is marketed in the U.S. by Janssen, L.P. and was approved for the treatment of schizophrenia in the U.S. in 2003.
The new 12.5 mg dose of RISPERDAL® CONSTA® is expected to be available in the U.S. market by May 1.
According to Henry Nasrallah, M.D., Professor of Psychiatry and Neuroscience, and Director of the Schizophrenia Research Program at the University of Cincinnati:
"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. 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 12.5 mg dose 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) which will provide physicians with more options to individualize treatment approaches and adjust therapies when clinical factors call for dosage changes.
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