Iloperidone was associated with significant improvement in adults with bipolar I disorder, according to results from a phase 3 study.
Iloperidone, an atypical antipsychotic, is currently marketed under the brand name Fanapt for the treatment of schizophrenia in adults. The VP-VYV-683-3201 study (ClinicalTrials.gov Identifier: NCT04819776) evaluated the efficacy and safety of iloperidone in approximately 400 adults with a history of bipolar I disorder who had a current episode of mania. Patients were randomly assigned 1:1 to receive either iloperidone or placebo.
Findings showed patients treated with iloperidone had significantly larger improvements vs placebo based on the change from baseline in the Young Mania Rating Scale (YMRS) total score at week 4 (primary endpoint; P =.000008). Significant improvements were observed as early as week 2. Secondary outcomes, including the Clinician Global Impression of Severity (P =.0005) and Clinician Global Impression of Change (P =.0002), were also met.
“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, Vanda’s President, CEO and Chairman of the Board. “We look forward to submitting our supplemental New Drug Application to the FDA and expanding the Fanapt franchise.”
Fanapt® shown to be effective in bipolar I disorder in phase III clinical study. News release. Vanda Pharmaceuticals Inc. 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.
This article originally appeared on MPR