Keypoint: Patients treated with iloperidone had significantly larger improvements vs placebo based on the change from baseline in the Young Mania Rating Scale total score.
The Food and Drug Administration (FDA) has expanded the approval of Fanapt® (iloperidone) to include the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt is also indicated for the treatment of schizophrenia in adults.
The expanded approval was based on data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04819776) that evaluated the efficacy and safety of iloperidone, an atypical antipsychotic, in 414 adults with a history of bipolar I disorder who had a current episode of mania. Patients were randomly assigned 1:1 to receive either oral iloperidone (n=206) or placebo (n=208).
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; treatment difference: -4.0 [95% CI, -5.7, -2.25]; P =.000008). Significant improvements were observed as early as week 2. Secondary endpoints, including change from baseline in the Clinician Global Impression of Severity (P =.0005) and Clinician Global Impression of Change (P =.0002) scores, were also statistically significant.
The safety profile of iloperidone was found to be consistent with previous trials in patients with schizophrenia. The most common adverse reactions reported were tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, weight gain, and somnolence.
“With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile,” said Mihael H. Polymeropoulos MD, Vanda’s President, CEO and Chairman of the Board. “This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder.”
Note: This article originally appeared on MPR