Alkermes, Inc. recently announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., has submitted a Supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection) to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD). FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor’s care. The condition may affect 10 to 20 percent of the 27 million people with bipolar disorder worldwide. The sNDA is based on results from a recent study comparing patients who received RISPERDAL CONSTA and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when RISPERDAL CONSTA was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008. RISPERDAL CONSTA was approved for the treatment of schizophrenia in the U.S. in 2003. RISPERDAL CONSTA is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is manufactured by Alkermes.
