Bristol Myers Squibb (NYSE: BMY) announced results from a Phase 4 clinical trial examining the transition from oral atypical antipsychotics to COBENFY (xanomeline and trospium chloride) in adult outpatients with schizophrenia. The 8-week study showed patients maintained symptom stability regardless of whether they switched medications over a 2-week or 4-week period.

The open-label trial included 105 adults with schizophrenia who were switched from their existing atypical antipsychotic to COBENFY using two different cross-titration strategies. One group tapered their previous medication over 2 weeks while the other group used a 4-week tapering schedule. Both groups simultaneously increased COBENFY to the target dose of 125/30 mg twice daily over two weeks.

Approximately 86% of patients completed the 8-week treatment period, with discontinuation rates of 15.1% in the slower transition group and 13.5% in the faster transition group. No patients discontinued treatment due to lack of efficacy. Mean changes in Positive and Negative Syndrome Scale scores from baseline to week 8 were -4.2 in the slower group and -3.1 in the faster group.

The study found 49% of patients experienced at least one treatment-emergent adverse event, with none classified as serious. The adverse event rates were consistent with previous COBENFY clinical trials. In the slower and faster transition groups, 1.9% and 3.8% of patients respectively discontinued treatment due to adverse events.

COBENFY was approved by the FDA in September 2024 as the first new mechanism for treating schizophrenia in decades. The medication combines xanomeline, a muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist. Data from this switching study were presented at the 2026 Annual Congress of the Schizophrenia International Research Society in Florence, Italy.