Bristol Myers Squibb (BMY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for COBENFY (xanomeline and trospium chloride), an oral medication designed to treat schizophrenia in adults.
The FDA's approval is underpinned by findings from the EMERGENT clinical program, which highlighted statistically significant reductions in the symptoms of schizophrenia.
In conjunction with the approval, Bristol Myers Squibb has launched COBENFY Cares, a patient support program for those prescribed COBENFY. Enrollment for COBENFY Cares will open in late October to align with the medication's availability.
COBENFY, previously known as KarXT, is a combination of xanomeline, a dual M 1 - and M 4 -preferring muscarinic receptor agonist, and trospium chloride, a muscarinic receptor antagonist that does not significantly cross the blood-brain barrier, hence acting mainly in peripheral tissues.
Schizophrenia is a chronic and debilitating mental illness that affects a person's thinking, emotions, and behavior. It presents in three primary symptom domains: positive symptoms (e.g., hallucinations, delusions, disordered thinking, and speech), negative symptoms (e.g., lack of motivation, emotional expression, and social withdrawal), and cognitive dysfunction (e.g., impaired attention, memory deficits, and trouble with decision-making). Schizophrenia impacts nearly 24 million individuals globally.
