FDA Approves Iloperidone for Acute Treatment of Manic, Mixed Episodes in Bipolar I

Drug Topics April 4, 2024
Lauren Biscaldi, MS, Managing Editor

The FDA has approved iloperidone tablets (Fanapt) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The atypical antipsychotic agent was initially approved in 2009 for the acute treatment of schizophrenia.¹

Bipolar disorder affects approximately 2.8% of adults in the United States; 83% of these cases are considered severe. Bipolar I disorder with manic or mixed episodes comprise a subset of the approximately 10 million Americans living with the disease.

“Many patients are still unable to find suitable treatment options for effectively managing bipolar disorder,” said Stephen Stahl, MD, PhD, professor of psychiatry at the University of California San Diego, in a press release.¹ “Tailoring the right treatment for the right patient is...

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