The US Food and Drug Administration (FDA) has accepted Karuna Therapeutics’ new drug application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults.
Schizophrenia is a long-lasting mental illness that can significantly affect a person’s thoughts, emotions, and behaviours. It impacts nearly 24 million people globally, with 2.8 million affected in the US.
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic under development to treat schizophrenia and psychosis related to Alzheimer’s disease.
Via its novel mechanism of action, the drug serves as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is believed to enhance positive, negative, and cognitive symptoms of schizophrenia.
The NDA submission was based on efficacy and long-term safety data from the EMERGENT programme, which is assessing KarXT as a treatment for this condition.
The programme consists of three completed positive studies, EMERGENT-1, EMERGENT-2, and EMERGENT-3, assessing the therapy’s efficacy and safety compared with a placebo.
Furthermore, the EMERGENT-4 and EMERGENT-5 trials are assessing the long-term safety of the therapy.
KarX achieved the primary endpoint in all three placebo-controlled studies. It showed statistically significant and clinically meaningful improvements in schizophrenia symptoms against placebo as measured by the Positive and Negative Syndrome Scale (PANSS) total score.
Karuna Therapeutics president and CEO Bill Meury said: “There is a significant need for new treatment options for serious mental illness.
“If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia.”