Key Takeaways
- Bristol Myers Squibb (BMS) will showcase new clinical and health economics outcomes research (HEOR) data on COBENFY™ for schizophrenia at Psych Congress 2024.
- Presentations include findings from the EMERGENT clinical trials, highlighting long-term safety, efficacy, and patient satisfaction.
- BMS remains focused on advancing neuropsychiatry treatments and improving patient outcomes.
Bristol Myers Squibb (NYSE: BMY) has announced that it will present new clinical and Health Economics and Outcomes Research (HEOR) data for its schizophrenia treatment, COBENFY™ (xanomeline and trospium chloride), at the upcoming Psych Congress 2024. This event, scheduled for October 29 – November 2 in Boston, Massachusetts, will feature key presentations from the company’s neuropsychiatry portfolio, including data from the long-term EMERGENT-4 and EMERGENT-5 clinical trials. These 52-week, open-label studies focus on assessing the safety, efficacy, and patient satisfaction of COBENFY in adults diagnosed with schizophrenia. Following the recent approval of COBENFY by the U.S. Food and Drug Administration (FDA), the presentations aim to provide further insights into its differentiated clinical profile, offering critical information for healthcare providers and patients.
The EMERGENT clinical trial program, central to BMS’s research efforts, continues to build momentum in the field of schizophrenia treatment. COBENFY combines xanomeline, a muscarinic receptor agonist, with trospium chloride, an antimuscarinic that limits peripheral side effects. This combination allows the drug to target both the M1 and M4 muscarinic acetylcholine receptors in the central nervous system, potentially reducing cognitive impairment and negative symptoms associated with schizophrenia. Alyssa Johnsen, MD, PhD, Senior Vice President and Head of Clinical Development at BMS, stated, “Our new data presentations at Psych Congress underscore the unique clinical benefits of COBENFY, which include improved patient outcomes and long-term safety. We are excited to further our neuropsychiatry portfolio and deliver innovative options for schizophrenia patients.”
Clinical and Health Economics Data Highlights
The presentations at Psych Congress will showcase a range of findings from both clinical and HEOR perspectives. Key clinical data include long-term safety and efficacy outcomes from the EMERGENT-4 and EMERGENT-5 trials, demonstrating the tolerability and effectiveness of COBENFY over a 52-week period. These studies explore how the treatment impacts not only clinical outcomes but also patient satisfaction, a crucial component for those managing a chronic condition like schizophrenia. Furthermore, additional studies focus on quality-of-life improvements for schizophrenia outpatients receiving COBENFY, based on in-depth patient interviews conducted during clinical trials.
In the health economics domain, BMS will present analyses that evaluate the real-world impact of COBENFY, including a comparative study examining its efficacy, safety, and tolerability versus eight other atypical antipsychotics used for schizophrenia treatment. This network meta-analysis provides a comprehensive understanding of COBENFY’s place in the therapeutic landscape, especially considering its recently approved status in the U.S. Moreover, HEOR data from the NeuroBlu database offer insights into negative symptoms and cognitive impairment in U.S. patients, contributing to the broader knowledge base on schizophrenia and its management. These findings help position COBENFY as a differentiated treatment option in the field, emphasizing BMS’s commitment to innovation in mental health.
COBENFY’s Role in Addressing Unmet Needs in Schizophrenia Treatment
COBENFY, formerly known as KarXT, is designed as an oral medication targeting muscarinic receptors to improve the management of schizophrenia’s cognitive and negative symptoms, areas often inadequately addressed by existing therapies. Schizophrenia affects millions globally, causing significant disruptions in cognition, behavior, and daily functioning. Despite available treatments, many patients continue to struggle with negative symptoms such as lack of motivation, social withdrawal, and cognitive impairments, which complicate their quality of life and recovery. BMS’s long-term focus is on providing more effective and tolerable options for patients, as reflected in the EMERGENT trials and other ongoing research.
The safety profile of COBENFY is also a focal point of the company’s clinical development program. BMS’s research includes monitoring the incidence of adverse reactions such as urinary retention, liver function abnormalities, and gastrointestinal issues associated with trospium chloride, one of COBENFY’s components. The company is committed to providing comprehensive safety information, ensuring that healthcare professionals can make informed decisions when prescribing COBENFY. By combining clinical efficacy with patient-centric safety monitoring, BMS aims to set a new standard in the treatment of schizophrenia, addressing both the clinical and quality-of-life aspects that are essential for long-term patient management.
BMS’s Continued Commitment to Neuropsychiatry Research
Bristol Myers Squibb’s participation in Psych Congress 2024 highlights its dedication to expanding treatment options and advancing research in neuropsychiatry. The company remains focused on delivering innovative solutions that enhance patient care and outcomes, particularly in the complex landscape of schizophrenia. BMS’s presentations at the congress will provide a platform for discussing COBENFY’s long-term impact and its potential to reshape the management of schizophrenia. The company is also exploring further regulatory and clinical pathways to expand COBENFY’s availability beyond the U.S., aiming to reach a broader patient population.
With a robust pipeline and ongoing research initiatives, BMS emphasizes its long-term commitment to developing advanced treatments that meet unmet needs in neuropsychiatry. This event serves as an important milestone for the company as it shares its findings and engages with healthcare professionals and stakeholders, highlighting the significant progress being made in addressing one of the most challenging mental health conditions.
Source: Bristol Myers Squibb, October 28, 2024
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