Lurasidone Gains New Indication for Bipolar Depression

The U.S. Food and Drug Administration (FDA) has approved new indications for the atypical antipsychotic drug lurasidone (Latuda; Sunovion) in treatment of patients with depressive episodes associated with bipolar I disorder. The approval covers use alone and as adjunctive therapy with lithium or valproate.

“Its utility as monotherapy and adjunctive therapy places the drug in a select position in an area with few other medication choices,” said Roger McIntyre, M.D., a professor of psychiatry and pharmacology at the University of Toronto, in an interview. Lurasidone was already approved for use in patients with schizophrenia.

With the new indications, the drug appeared to cause fewer metabolic problems or weight gain than other drugs in its class, said McIntyre, who formerly consulted with Sunovion’s Canadian affiliate, but does not do so now.

In two clinical trials submitted to the FDA, lurasidone was tested over its complete dosing range of 20mg to 120 mg day, and average weight gain was 0.3 kg with monotherapy and 0.1 kg with adjunctive use, said psychiatrist Antony Loebel, M.D., chief medical officer at Sunovion. Trial results were presented as posters at APA's 2012 annual meeting and have been submitted for publication.

The new indication should help fill the unmet need for more treatment options for clinicians and their patients with bipolar depression, said Loebel.

For more in Psychiatric News about medications used to treat bipolar depression, click here.

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