Positive Phase III Study Results Reported for Bipolar I Disorder Treatment in Adults

The novel atypical antipsychotic is already FDA-approved for the treatment of schizophrenia in adults.

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A Phase III clinical study of Fanapt iloperidone tablets has reported positive results for the treatment of acute manic and mixed episodes related to bipolar I disorder in adults.

Fanapt, a novel atypical antipsychotic that is already approved by the US Food and Drug Administration (FDA) as a treatment for schizophrenia in adults, is being investigated by Vanda Pharmaceuticals Inc in clinical study VP-VYV-683-3201. In the Phase III study, 400 volunteers with a history of bipolar disorder who were experiencing an episode of mania were randomized to receive either Fanapt or placebo in a ratio of 1:1.1

Upon assessing the treatment over 4 weeks using the Young Mania Rating Scale (YMRS), the investigators found at the primary endpoint of Week 4 that the participants who received Fanapt demonstrated a statistically significant greater improvement than the participants who were treated with placebo (p=0.000008).1

This improvement began showing statistical significance in the week 2 assessment, with other outcomes including Clinician Global Impression of Change (CGI-C) and Clinician Global Impression of Severity (CGI-S) also showing statistical significance at p=0.0002 and p=0.0005, respectively.1

“The robust clinical trial results we report today demonstrate the potential to extend the utility of Fanapt into treating adult patients with bipolar I disorder, in addition to the already marketed indication of schizophrenia,” said Mihael H. Polymeropoulos, MD, president, CEO and chairman of the board at Vanda, in a press release. “We look forward to submitting our supplemental New Drug Application (sNDA) to the FDA and expanding the Fanapt franchise.”

Vanda plans to submit an sNDA for Fanapt for the treatment of acute and manic mixed episodes connected to bipolar I disorder in adults in 2023.1

Reference

1. Fanapt shown to be effective in bipolar I disorder in phase III clinical study. Cision PR Newswire. News release. December 19, 2022. Accessed December 19, 2022. https://www.prnewswire.com/news-releases/fanapt-shown-to-be-effective-in-bipolar-i-disorder-in-phase-iii-clinical-study-301705863.html

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