Bristol Myers Squibb's COBENFY Gains FDA Approval For Adult Schizophrenia Treatment

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(RTTNews) - Bristol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration has approved COBENFY (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.

The approval is supported by data from the EMERGENT clinical program, which demonstrates statistically significant reductions in schizophrenia symptoms.

Bristol Myers also announced the launch of COBENFY Cares, a program designed to support patients who have been prescribed COBENFY. Patients will be able to enroll in the COBENFY Cares program in late October corresponding with product availability.

COBENFY (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. COBENFY combines xanomeline, a dual M 1 - and M 4 -preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily acting in peripheral tissues.

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). Schizophrenia affects nearly 24 million people worldwide.

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