FDA Broadens Approval for Antipsychotic Drug Risperdal to Treat Bipolar Disorder

An injectible form of Risperdal Consta, a drug previously approved to treat schizophrenia and bipolar mania, may now be used for patients with bipolar I disorder, the Food and Drug Administration said.

The FDA broadened its approvals for the drug made by Janssen Pharmaceuticals, a division of Johnson & Johnson. The pill form of Risperdal Consta was already approved as a standalone schizophrenia treatment and for use in conjunction with lithium or valproate. It also is used to treat autism.

Type I bipolar disorder is marked by more than one manic episode which occurs with or without an episode of major depression. The condition may also result in episodes of hypomania or major depression.

Injectable Risperdal has been approved since 2003 for the treatment of schizophrenia. In February 2009, the FDA requested additional data on Risperdal Consta before approving it for more uses.

Two studies found that injectable Risperdal Consta effectively delayed relapses of bipolar I disorder, which causes extreme mood shifts. One study also showed the drug significantly delayed relapses when used as therapy with lithium or valproate.

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