FDA accepts KarXT new drug application for treating schizophrenia

The FDA has accepted a new drug application from Karuna Therapeutics for KarXT, an investigational muscarinic antipsychotic for the treatment of schizophrenia in adults, the company announced in a press release.

According to the release, KarXT (xanomeline-trospium) acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which may improve positive, negative and cognitive symptoms of schizophrenia. Unlike current treatments, KarXT does not directly block dopamine receptors.

The NDA submission is supported by efficacy and long-term safety results from the EMERGENT program, which includes five trials. The first three evaluated the drug’s safety and efficacy compared with placebo, and the last two tested long-term safety.

KarXT demonstrated statistically significant and clinically meaningful improvement in symptoms in the three placebo-controlled trials, the release stated, and was well-tolerated, with mild to moderate cholinergic adverse events. It was not associated with common antipsychotic medication side effects like weight gain, somnolence or movement disorders.

“We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” Bill Meury, Karuna’s president and CEO, said in the release. “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.”

The application for KarXT has received a PDUFA date of Sept. 26, 2024.