Summary

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• This summary is based on the review of two randomized controlled trials. ^[1-2]
• Bysanti (milsaperidone) is indicated for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
• Milsaperidone is an active metabolite, or pro-drug, that rapidly converts to iloperidone in vivo.
• In adults with schizophrenia, iloperidone reduced relapse compared to placebo, with relapse rates of 20.4% vs 63.4% (p < 0.0001) and mean time to relapse of 139 days vs 71 days (hazard ratio 4.7; 95% confidence interval 2.7–8.3; p < 0.0001).
• In adults with bipolar mania, iloperidone reduced symptoms as measured by Young Mania Rating Scale (YMRS) total score, with a least-squares mean difference of -4.0 from baseline to week 4 (95% CI: -5.70 to -2.25; adjusted P = .000008).
• In adults with schizophrenia, common adverse events with iloperidone included dizziness (11.6%), somnolence (8.3%), and dry mouth (6.8%), with low incidence of extrapyramidal symptoms (EPS) (2.5%) and akathisia (3.7%).
• In adults with bipolar mania, common adverse events included tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, increased weight, and somnolence; extrapyramidal symptoms and akathisia were reported as low incidence, with no new safety concerns identified.
• Adults with schizophrenia and adults with bipolar mania were included; no specific subgroup analyses were reported for either population.