The FDA has approved a first-in-class antipsychotic that targets cholinergic receptors without blocking dopamine receptors.
"This drug takes the first new approach to schizophrenia treatment in decades," Tiffany Farchione, MD, director of the Division of Psychiatry, Office of Neuroscience, in the FDA's Center for Drug Evaluation and Research, said in a news release announcing the approval.
The EMERGENT-2 and EMERGENT-3 trials both met their primary endpoints, demonstrating statistically significant reductions of schizophrenia symptoms compared with placebo, as measured by the Positive and Negative Syndrome Scale total score change from baseline to week 5. Secondary endpoints included change in PANSS positive subscale, PANSS negative subscale, PANSS Marder negative factor, Clinical Global Impression-Severity score, and percentage of participants achieving at least a 30% reduction from baseline to week 5 in PANSS total score.Unlike other antipsychotics, xanomeline/trospium did not cause weight gain or extrapyramidal symptoms.
Patients should be advised to stop using xanomeline/trospium if they experience signs or symptoms of substantial liver disease, including yellowing of the skin or the white part of the eyes, dark urine, and unexplained itching.
Receptors Antipsychotics Neuroleptics Neuroleptic Drugs Liver Disease Hepatic Impairment Atypical Antipsychotics Second Generation Antipsychotics Dopamine Gastroesophageal Reflux Disease GERD Acid Reflux Disease Gastroesophageal Reflux Gastro-Oesophageal Reflux Disease Gastro-Oesophageal Reflux Impairment Liver Renal Failure Renal Insufficiency Kidney Insufficiency
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