Bristol Myers Squibb (BMS) is presenting new clinical data and health economics and outcomes research on COBENFY™ (xanomeline and trospium chloride) at Psych Congress. The presentations will highlight the differentiated clinical profile of COBENFY, including efficacy, safety, and patient-reported outcomes in adults with schizophrenia who participated in the EMERGENT clinical trial program.
COBENFY Data Presentations
Several poster presentations will feature data from the EMERGENT trials, including:
- Long-Term Safety and Efficacy: Results from the 52-week, open-label EMERGENT-4 and EMERGENT-5 trials will be presented, detailing the long-term safety, tolerability, and efficacy of xanomeline and trospium chloride in patients with schizophrenia.
- Patient-Reported Outcomes: Qualitative interview-based studies will explore patient satisfaction and changes in quality of life among schizophrenia outpatients receiving xanomeline and trospium chloride.
- Efficacy Analyses: Post hoc analyses of pooled data from three 5-week, randomized, double-blind, placebo-controlled EMERGENT trials will examine the efficacy of xanomeline and trospium chloride.
- Agitation Reduction: Data from three randomized, double-blind, placebo-controlled trials will assess the impact of xanomeline and trospium chloride on agitation in schizophrenia, measured by the PANSS-EC.
- Metabolic Outcomes: Interim results from pooled, long-term safety studies EMERGENT-4 and EMERGENT-5 will provide insights into the long-term metabolic outcomes associated with xanomeline and trospium chloride.
- Participant Experience: In-trial qualitative interviews will explore participant experiences with xanomeline and trospium chloride treatment, focusing on perceived effects on symptoms during a long-term Phase 3 trial.
Health Economics and Outcomes Research
Presentations on health economics and outcomes research include:
- Real-World Data: A descriptive study using the NeuroBlu database will examine negative symptoms and cognitive impairment in US patients with schizophrenia.
- Network Meta-Analysis: A network meta-analysis will compare the efficacy, safety, and tolerability of xanomeline and trospium chloride versus eight atypical antipsychotics for the acute treatment of adults with schizophrenia.
- Epidemiology: Current estimates of the incidence and prevalence of schizophrenia in the U.S. will be presented.
About COBENFY (xanomeline and trospium chloride)
COBENFY is an oral medication indicated for the treatment of schizophrenia in adults. It combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that primarily confines its effects to peripheral tissues. The efficacy of COBENFY is thought to be due to the agonist activity of xanomeline at M1 and M4 muscarinic acetylcholine receptors in the central nervous system.
Schizophrenia: A Significant Global Health Issue
Schizophrenia is a persistent and often disabling mental illness affecting nearly 24 million people worldwide, including 2.8 million in the United States. It is characterized by positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., lack of motivation, social withdrawal), and cognitive dysfunction (e.g., impaired attention, memory deficits). These symptoms can significantly impact a person's ability to maintain employment, live independently, and manage relationships.