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FDA accepts NDA for novel combo therapy for schizophrenia

December 5, 2023

On November 29, Karuna Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for xanomeline-trospium (KarXT) for the treatment of schizophrenia in adults. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

• Xanomeline-trospium is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer disease. The combination therapy acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the CNS, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, the new drug does not directly block dopamine receptors.
• The NDA submission is supported by data from the EMERGENT program, which includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of xanomeline-trospium compared with placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of the combination.
• In all three placebo-controlled trials, xanomeline-trospium demonstrated statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared with placebo as measured by Positive and Negative Syndrome Scale (PANSS) total score. The drug was found to be generally well tolerated, with the most common adverse events being mild to moderate cholinergic effects. Notably, it wasn’t associated with common side effects seen with currently available antipsychotics, including weight gain, somnolence, and movement disorders.

Source:

Karuna Therapeutics. (2023, November 29). Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia. [Press release]. https://investors.karunatx.com/news-releases/news-release-details/karuna-therapeutics-announces-us-food-and-drug-administration