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(Reuters) -The U.S. Food and Drug Administration approved Bristol Myers Squibb's schizophrenia drug late on Thursday, making it the first new type of antipsychotic medicine in decades. The ...
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb ...
In September 2024, it was approved for medical use in the United States. [ 1 ] [ 2 ] It is the first antipsychotic drug approved by the US Food and Drug Administration (FDA) to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors , which has long been the standard of care.
The medicine works in an entirely different way from existing treatments.
The Brief Negative Symptom Scale (BNSS) has been used to assess the effect of Ulotaront on the negative symptoms of schizophrenia. [18] In July 2023, the pharmaceutical company behind the drug announced that the drug had failed to outperform placebo in the treatment of acutely psychotic patients with schizophrenia, as measured by the PANSS. [19]
RECOVER-2 is a confirmatory 4-week, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of 450 acute schizophrenia patients, where patients will receive brilaroxazine 30 mg, 50 mg, or placebo once daily. Completion is expected in Q2 2025 and brilaroxazine FDA new drug application (NDA) submission is expected in Q3 ...
Some people who took a new schizophrenia drug for a year improved with only a few side effects, but many dropped out of the research, the company announced Thursday. The results underscore the difficulties in treating schizophrenia, a severe mental illness that can cause people to hear voices, feel paranoid and withdraw from others. High ...
The U.S. Food and Drug Administration (FDA) on Friday approved a new drug used for treating schizophrenia in adults, according to a press release. “This drug takes the first new approach to ...
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