<p>Xanomeline/trospium chloride (COBENFY<sup>™</sup>) is a promising new treatment option for schizophrenia in the USA. The orally administered, first-in-class drug is composed of xanomeline, an M<sub>1</sub> and M<sub>4</sub> receptor selective muscarinic agonist, and trospium chloride, a peripherally restricted, non-selective muscarinic antagonist. Across one phase&#xa0;2 and two phase 3 inpatient studies in adult patients with schizophrenia experiencing acutely exacerbated psychosis, twice-daily treatment with xanomeline/trospium chloride for 5&#xa0;weeks significantly improved schizophrenia symptoms compared with placebo. Additionally, two long-term, open-label, phase&#xa0;3 studies demonstrated the efficacy of xanomeline/trospium chloride for up to 52&#xa0;weeks. Xanomeline/trospium chloride therapy is generally well tolerated. Across the short- and long-term trials, most adverse events were gastrointestinal, of mild or moderate severity, and transient in nature. Xanomeline/trospium chloride treatment was associated with a low risk of extrapyramidal symptoms or metabolic disturbances.</p>

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Xanomeline/trospium chloride in schizophrenia: a profile of its use

  • Aisling McGuigan,
  • Hannah A. Blair

摘要

Xanomeline/trospium chloride (COBENFY) is a promising new treatment option for schizophrenia in the USA. The orally administered, first-in-class drug is composed of xanomeline, an M1 and M4 receptor selective muscarinic agonist, and trospium chloride, a peripherally restricted, non-selective muscarinic antagonist. Across one phase 2 and two phase 3 inpatient studies in adult patients with schizophrenia experiencing acutely exacerbated psychosis, twice-daily treatment with xanomeline/trospium chloride for 5 weeks significantly improved schizophrenia symptoms compared with placebo. Additionally, two long-term, open-label, phase 3 studies demonstrated the efficacy of xanomeline/trospium chloride for up to 52 weeks. Xanomeline/trospium chloride therapy is generally well tolerated. Across the short- and long-term trials, most adverse events were gastrointestinal, of mild or moderate severity, and transient in nature. Xanomeline/trospium chloride treatment was associated with a low risk of extrapyramidal symptoms or metabolic disturbances.