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BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

Shots:

  • The P-III (ARISE) trial assessed Cobenfy (xanomeline & trospium chloride) vs PBO as an adj. therapy to atypical antipsychotics in adults with inadequately controlled schizophrenia symptoms; eligible pts could enter a 52wk. OLE study
  • At Wk. 6, trial showed a PANSS score change (1EP) of -14.3 vs -12.2, which was not statistically significant, & changes in 2EPs, incl. PSP (+5.3 vs +5.9) & CGI-S score (-0.6 vs -0.5)
  • In post-hoc analysis, the risperidone subgroup showed PANSS score change of -11.3 vs -12.3, while non-risperidone subgroup showed improvement of -15.1 vs -11.7; further analysis is underway, plus discussions with regulators are planned. Full data to be presented at future meetings   

Ref: Businesswire | Image: BMS

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