Karuna Therapeutics announces FDA accepted NDA for KarXT

Karuna Therapeutics announced the FDA has accepted its New Drug Application or NDA, for KarXT, or xanomeline-trospium, for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act date of September 26, 2024. The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT. In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared to placebo as measured by Positive and Negative Syndrome Scale total score. KarXT was found to be generally well tolerated, with the most common adverse events being cholinergic in nature and mild to moderate in severity. Notably, KarXT was not associated with common side effects of currently available antipsychotics, including weight gain, somnolence, and movement disorders.