Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia
KarXT, a dual M1/M4 muscarinic agonist, represents the first new mechanism of action to treat schizophrenia in several decades, if approved
Submission is supported by data from three positive registrational trials demonstrating consistent and robust reductions of schizophrenia symptoms
"Schizophrenia is a serious mental illness that affects how one thinks, feels, and behaves, with symptoms often appearing in patients in early adulthood, during the prime years of their lives,” said
“The NDA submission represents an important step toward helping patients in need. It is also a defining moment for
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 ongoing 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 a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. KarXT also demonstrated reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS negative Marder factor subscales, which were secondary endpoints in the trials.
KarXT was found to be generally well-tolerated, with the most common adverse events being cholinergic in nature and rated mild to moderate in severity. Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials. Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms.
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to mediate positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the
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