Segal Trials is honored to have contributed significantly to the FDA approval of COBENFY™ (xanomeline and trospium chloride), a groundbreaking first-in-class muscarinic agonist developed by Bristol Myers Squibb for the treatment of schizophrenia in adults. This approval marks a critical advancement in schizophrenia care, offering new hope to those living with the condition.
A Major Leap Forward in Schizophrenia Treatment
COBENFY™ provides a fresh approach to schizophrenia treatment by targeting muscarinic receptors, offering patients a reduction in symptoms of psychosis with fewer metabolic side effects than traditional antipsychotics. This novel pathway represents a major step forward in treatment options, improving both patient outcomes and quality of life (Patient Care Online)(BMS News).
Segal Trials' Longstanding Involvement
Segal Trials has been involved with COBENFY™ from its early development under Karuna Therapeutics. Our partnership began during the initial phases of the EMERGENT program and continued after Bristol Myers Squibb acquired Karuna and brought COBENFY™ to market. Throughout this process, Segal Trials provided essential data across multiple phases, contributing to the pivotal clinical trials that led to FDA approval. This enduring partnership highlights Segal Trials' leadership in schizophrenia research, built on over 20 years of expertise.
A Transformative Moment for Mental Health Care
Dr. Rishi Kakar, Chief Scientific Officer at Segal Trials, remarked, “The FDA’s approval of COBENFY™ is a monumental step forward in schizophrenia treatment. We are proud to have contributed to this breakthrough, which will offer patients and clinicians a much-needed alternative in mental health care.”
Bonnie Segal, President of Segal Trials, added, “Our involvement with this groundbreaking treatment spans many years, from working with Karuna Therapeutics when the drug was originally known as KarXT, to continuing our partnership with Bristol Myers Squibb after the acquisition and rebranding of the drug as COBENFY™. This approval highlights the strength of longstanding collaborations in clinical research, and we are honored to have been part of bringing such an innovative treatment to patients."
Media Recognition
This groundbreaking approval has gained significant attention from leading publications, further underscoring the importance of COBENFY™ in the field of mental health:
● TIME: FDA Approves the First New Schizophrenia Drug in Decades
● MedPage Today: FDA Approves First-in-Class Schizophrenia Drug
● Investopedia: Bristol Myers Squibb Stock Rises After FDA Approval
Looking Ahead
As we celebrate this approval, Segal Trials is reminded of the immense potential that clinical research holds in improving patient outcomes. We remain committed to advancing treatments for mental health conditions through ongoing research and innovation.
For more information, visit: Segal Trials and the official Bristol Myers Squibb press release.