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FDA Approves Iloperidone for Adults With Bipolar 1 Disorder


Vanda Pharmaceuticals announces the FDA approval of iloperidone (Fanapt) for the acute treatment of bipolar 1 disorder.

Iloperidone (Fanapt) received approval from the FDA for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults, according to a statement released by Vanda Pharmaceuticals.1

Iloperidone is a second-generation atypical antipsychotic agent for managing symptoms of bipolar mania. In 2009, the FDA approved it for the treatment of schizophrenia in adults, although the label warns that for older patients with dementia-related psychosis, iloperidone comes with an increased risk of death.2

"Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder. Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone," Stephen Stahl, MD, PhD, professor of Psychiatry at the University of California San Diego, said in the statement.1 "Fanapt possesses a well-studied safety profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder."

FDA | Image Credit: wladimir1804 - stock.adobe.com

FDA | Image Credit: wladimir1804 - stock.adobe.com

In January, Vanda published the phase 3 clinical trial data and submitted them with the supplemental new drug application for iloperidone in the treatment of bipolar 1 disorder in adults. The data demonstrated significant improvement in patients who received iloperidone compared with the placebo group across primary and secondary end points.3

The primary objective of the study was the change in Young Mania Rating Scale (YMRS) total score from baseline to week 4 compared with placebo. Secondary efficacy end points included changes in the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales.

The randomized, double-blind, placebo-controlled study was conducted across 27 sites in the US and internationally from April 2021 to September 2022 among adults with diagnosed bipolar mania. Participants were randomly assigned to receive either iloperidone, with doses reaching up to 24 mg/day given twice daily, or placebo over 4 weeks.

Iloperidone exhibited significant improvement compared with placebo across primary and secondary end points at week 4. The analysis indicated a substantial reduction in YMRS total scores, with a difference in least-squares mean of –4.0 (95% CI, −5.70 to −2.25; P = .000008).

A total of 414 participants received at least 1 dose of iloperidone (n = 206) or placebo (n = 208). The dropout rate due to adverse events was 18 patients who received iloperidone and 11 patients from the placebo group, resulting in 67.1% of iloperidone patients and 72.9% of placebo patients completing the study.

Common adverse events included tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, weight gain, and somnolence. According to the study investigators, the incidence of akathisia and extrapyramidal symptom–related treatment-emergent adverse events remained low.

The safety profile observed in the study was in line with previous clinical investigations involving patients with schizophrenia, indicating consistency and no new safety concerns.

"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," Mihael H. Polymeropoulos MD, president and CEO of Vanda, said in the statement.1 "With over 100,000 patient years of experience, Fanapt 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."


1. Vanda Pharmaceuticals' Fanapt (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder. News release. Vanda Pharmaceuticals Inc. April 2, 2024. Accessed April 2, 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. Manalac T. FDA action alert: Vanda, Basilea and J&J/Legend. BioSpace. April 1, 2024. Accessed April 2, 2024. https://www.biospace.com/article/fda-action-alert-vanda-basilea-and-j-and-j-legend/

3. Torres R, Czeisler EL, Chadwick SR, et al. Efficacy and safety of iloperidone in bipolar mania: a double-blind, placebo-controlled study. J Clin Psychiatry. 2024;85(1):23m14966. https://www.psychiatrist.com/jcp/efficacy-safety-iloperidone-in-bipolar-mania/

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