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Jake Goodman, MD, MBA is a psychiatry resident physician and a member of the ABC News Medical Unit. FDA approves 1st new drug for schizophrenia in more than 30 years originally appeared on abcnews ...
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 Friday approved a new drug used for treating schizophrenia in adults, according to a press release. “This drug takes the first new approach to ...
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]
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 ...
The Brief Negative Symptom Scale (BNSS) has been used to assess the effect of Ulotaront on the negative symptoms of schizophrenia. [16] 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. [17]
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