Bristol-Myers Squibb (BMS, NYSE: BMY) has announced top-line results from the Phase III ARISE trial of Cobenfy (xanomeline/trospium chloride), an adjunctive therapy to atypical antipsychotics for adults with inadequately controlled schizophrenia. The trial assessed the efficacy and safety of this novel combination.
Trial Outcomes
In the ARISE trial, patients receiving Cobenfy in addition to atypical antipsychotics showed a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to those receiving a placebo with atypical antipsychotics at Week 6. However, this reduction did not achieve statistical significance for the primary endpoint (P = 0.11). Post hoc analyses suggest potential benefits in specific patient subgroups, indicating a need for further research to identify responders.-Fineline Info & Tech
