Bristol Myers Squibb Highlights Promising Long-Term Data for COBENFY in Schizophrenia at Psych Congress 2024
Bristol Myers Squibb reported good long-term results from the EMERGENT study for COBENFY (xanomeline and trospium chloride) in adult schizophrenia patients. This is a big step forward. The data from the Phase 3 EMERGENT-4 and EMERGENT-5 studies, which lasted 52 weeks, showed consistent improvements in symptom management and a favourable safety profile. The 2024 Psych Congress in Boston hosted the presentation of the findings.
"The results of our long-term trials further support the differentiated profile of COBENFY and reinforce prior findings of robust and sustained symptom reduction with long-term treatment," said Dr. Alyssa Johnsen, senior vice president and head of clinical development for immunology, cardiovascular, and neuroscience at Bristol Myers Squibb. Dr. Johnsen emphasized the tolerability and consistency of COBENFY's outcomes, highlighting the drug's unique mode of action that aims to reduce common adverse effects like weight gain and metabolic abnormalities, which are common in antipsychotic medications. "With COBENFY now available for adults with schizophrenia, we look forward to further understanding the real-world impact of this differentiated treatment option," according to Dr. Johnsen.
In the EMERGENT-4 trial, 156 persons who had previously received COBENFY in short-term studies continued to improve in major schizophrenia symptoms, including lower scores on the Positive and Negative Syndrome Scale (PANSS). The study found that 69% of patients improved their symptoms by ≥30% compared to their acute trial baseline. Importantly, only 11% discontinued COBENFY due to adverse effects, most of which were mild to moderate in severity, such as nausea, vomiting, and dry mouth.
In the EMERGENT-5 trial, 566 patients who had stable symptoms following previous antipsychotic therapy began using COBENFY. Symptoms improved throughout the course of 52 weeks, according to established testing for schizophrenia severity. At the conclusion, 30% of subjects reported a 30% or greater reduction in symptoms. Dr. Johnson observed that there were no reports of mobility difficulties, metabolic issues, or significant weight changes. In fact, patients shed an average of 2.2 kg, highlighting COBENFY's distinct advantages.
The majority of participants in a qualitative study as part of EMERGENT-5 reported significant increases in physical, social, and emotional well-being. At six months, 93% of patients were satisfied with COBENFY, and 78% said they would continue the treatment if given the opportunity. A patient wrote: "COBENFY has significantly improved my social interactions and confidence, unlike my previous treatments."
Schizophrenia, a disabling disorder affecting roughly 24 million individuals worldwide, remains difficult to manage due to its wide range of symptoms and impact on daily life. This new research is a big step forward in the treatment of schizophrenia, as COBENFY has shown promise for improved symptom control and quality of life. According to Bristol Myers Squibb's results, COBENFY could be a new alternative for people suffering from schizophrenia who want an effective, long-term treatment with fewer side effect.