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FDA Approves Iloperidone for Acute Treatment of Bipolar I Disorder
Ilperidone, an atypical antipsychotic approved by US Food and Drug Administration (FDA) in 2009 for the treatment of schizophrenia and marketed under the name Fanapt by manufacturer Vanda Pharmaceuticals Inc., received FDA approval on Friday for acute treatment of manic or mixed episodes associated with bipolar I in adults.
"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, and founder of HMP Global’s Neuroscience Education Institute (NEI), said in the press release.
The approval was based on results from a phase III clinical study showcasing the efficacy of iloperidone tablets in managing acute manic and mixed episodes associated with bipolar I disorder in adults; the drug exhibited significant superiority over placebo in the trial.
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Conducted across clinical sites in the United States, Bulgaria, and Poland, the study involved approximately 400 volunteers with a history of bipolar I disorder experiencing a current manic episode. Patients were randomized to receive either iloperidone or placebo in a 1:1 ratio. Assessment using the Young Mania Rating Scale (YMRS) at week 4 revealed a substantial improvement in patients treated with ilperidone compared to those receiving placebo (p=0.000008).
Significant benefits of the drug over placebo were evident as early as the week 2 assessment, with consistent improvement observed throughout the 4-week study period across various parameters including Clinician Global Impression of Severity (CGI-S) and Clinician
Global Impression of Change (CGI-C) (p=0.0005 and p=0.0002, respectively).
Fanapt carries a black box warning indicating an increased risk of mortality in elderly patients with dementia-related psychosis and the drug is not approved for use in this population. “Analysis of 17 placebo-controlled trials (modal duration 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients,” the warning reads.
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