FDA Approves Cobenfy for Treatment of Schizophrenia in Adults

On Sept. 26, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.

 A press release on the approval said, “Schizophrenia can cause psychotic symptoms including hallucinations (such as hearing voices), difficulty controlling one’s thoughts and being suspicious of others. It can also be associated with cognitive problems and difficulty with social interactions and motivation. About 1% of Americans have this illness and globally it is one of the 15 leading causes of disability. Individuals with schizophrenia are at greater risk of dying at a younger age, and nearly 5% die by suicide.”

Further, “Cobenfy’s effectiveness for the treatment of schizophrenia in adults was evaluated in two studies with identical designs. Study 1 and Study 2 were 5-week, randomized, double-blind, placebo-controlled, multi-center studies in adults with a diagnosis of schizophrenia according to DSM-5 criteria.”

The approval of Cobenfy was granted to Bristol-Myers Squibb Company.