The FDA has approved Risperdal Consta (risperidone long-acting injection, from Janssen) for use as monotherapy or as adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder.  This approval is based on data from two prospective, randomized, double-blind, placebo-controlled studies for the long-term treatment of bipolar I disorder. The first study demonstrated that Risperdal Consta monotherapy was significantly better than placebo at delaying the time to relapse of any mood episode. The second study demonstrated that, for patients already taking lithium or valproate, the addition of Risperdal Consta significantly delayed the time to relapse compared to current treatments plus placebo.

Risperdal Consta is already indicated for the treatment of schizophrenia.

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