The US Food and Drug Administration (FDA) announced on Thursday that it has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
This approval was granted to US pharmaceutical company Bristol-Myers Squibb (NYSE:BMY).
Cobenfy is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors, as opposed to dopamine receptors. Its effectiveness for the treatment of schizophrenia in adults was assessed in two randomised, double-blind, placebo-controlled, multi-centre studies in adults with a diagnosis of schizophrenia based on DSM-5 criteria.
Tiffany Farchione, MD., director of the Division of Psychiatry, Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said: "Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person's quality of life. This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed."
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