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The nonprofit Institute for Clinical and Economic Review, which analyzes drug prices, said in January that the drug would be cost effective if priced between $16,000 and $20,000 per year.
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 ...
(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 ...
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. [2] [3]
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.
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 ...
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