Bristol Myers Squibb (NYSE: BMY) has announced FDA approval of COBENFY™ (xanomeline and trospium chloride), an oral medication for treating schizophrenia in adults. COBENFY is the first new class of schizophrenia treatment in decades, offering a novel approach by selectively targeting M1 and M4 receptors in the brain, while avoiding D2 receptor blockade.
“Today’s landmark approval of our first-in-class treatment for schizophrenia is a significant milestone, providing an entirely new pharmacological approach after over 30 years,” said Chris Boerner, PhD, board chair and CEO of Bristol Myers Squibb. “As we reenter neuropsychiatry, we aim to change the conversation around serious mental illness, starting with schizophrenia.”
Schizophrenia is a chronic and often debilitating mental disorder affecting approximately 2.8 million people in the U.S. Symptoms typically emerge in early adulthood and can vary widely, making diagnosis and management challenging. Current treatment options may not adequately improve symptoms for up to 60% of patients, who may also experience intolerable side effects.
“For individuals with schizophrenia, finding an effective treatment can be difficult. A range of options empowers patients and healthcare providers to better manage this serious condition,” noted Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “Today’s approval offers a new choice as individuals seek the support needed to rebuild their lives.”
The FDA’s approval of COBENFY is backed by the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label studies assessing long-term safety and tolerability. In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, COBENFY significantly reduced schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS). Specifically, COBENFY achieved a 9.6-point and an 8.4-point reduction in PANSS total score in EMERGENT-2 and EMERGENT-3, respectively.
The safety profile of COBENFY was established through acute and long-term trials. The most common adverse reactions (≥5% and at least twice the rate of placebo) included nausea, dyspepsia, constipation, vomiting, and hypertension. Notably, COBENFY does not carry atypical antipsychotic warnings and lacks a boxed warning.
“Schizophrenia’s heterogeneous nature means it’s not a one-size-fits-all condition,” said Rishi Kakar, MD, chief scientific officer at Segal Trials. “COBENFY’s approval is transformative, offering a new pathway to manage this challenging disorder.”
Bristol Myers Squibb also announced the launch of COBENFY Cares™, a program designed to support patients prescribed COBENFY, with enrollment expected to begin in late October.
About Schizophrenia:
Schizophrenia is a persistent mental illness that disrupts how a person thinks, feels, and behaves, characterized by positive symptoms (hallucinations, delusions), negative symptoms (lack of motivation, emotional expression), and cognitive dysfunction (impaired attention, memory). Affecting nearly 24 million people globally, including 2.8 million in the U.S., it is a leading cause of disability.
About COBENFY™ (xanomeline and trospium chloride):
COBENFY is an oral medication combining xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a peripheral muscarinic receptor antagonist. While its exact mechanism of action is unknown, efficacy is attributed to xanomeline’s activity at M1 and M4 receptors in the central nervous system.
About the EMERGENT Clinical Program:
The EMERGENT program includes three placebo-controlled efficacy and safety studies, featuring the Phase 3 EMERGENT-2 and EMERGENT-3 trials. Both trials showed statistically significant reductions in schizophrenia symptoms, confirming COBENFY’s potential as a new treatment option.
