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


The drug was previously approved in 2009 to treat schizophrenia.

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.

bipolar I disorder | image credt: Benjavisa Ruangvaree - stock.adobe.com

bipolar I disorder | image credt: Benjavisa Ruangvaree - stock.adobe.com

“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 critical for effective care, and the approval of [iloperidone] represents an important milestone.”

Iloperidone approval was based on a pivotal phase 3 study of 400 patients with bipolar I disorder.2 Patients were randomly assigned 1:1 to receive either iloperidone or placebo. At week 4, researchers used the Young Mania Rating Scale, a scale of clinical severity for core symptoms of mania, to evaluate improvement. By week 4, patients in the treatment group demonstrated a highly statistically significant improvement compared with the placebo group, with statistically significant benefits observed as early as week 2.

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“Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs,” said Mihael H. Polymeropoulos, MD, president and CEO of Vanda Pharmaceuticals. “[Iloperidone] is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder.”

Iloperidone includes a boxed warning for increased mortality in older patients with dementia-related psychosis. Individuals in that patient population who are treated with antipsychotic drugs are at an increased risk of death.

Other precautions include a risk of prolonged QT interval, which may be associated with arrhythmia and sudden death; its use should be avoided in combination with other drugs that prolong QTc. Risks for neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes increasing cardiovascular or cerebrovascular risk also exist.

The most common adverse reactions in bipolar mania include tachycardia, dizziness, dry mouth, nasal congestion, hypotension, somnolence, an increase in weight, and an increase in hepatic enzymes. Patients who are also receiving a strong CYP2D6 or CYP3A4 inhibitor should receive a reduced dose of iloperidone.

READ MORE: Mental and Behavioral Health Resource Center

1. Vanda Pharmaceuticals’ Fanapt (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder. News release. Vanda Pharmaceuticals. April 2, 2024. Accessed April 4, 2024. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-fanapt-iloperidone-receives-us-fda-approval-for-the-acute-treatment-of-bipolar-i-disorder-302106405.html
2. Fanapt shown to be effective in bipolar I disorder in phase III clinical study. News release. Vanda Pharmaceuticals. December 19, 2022. Accessed April 4, 2024. https://vandapharmaceuticalsinc.gcs-web.com/node/15146/pdf
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