Karuna Therapeutics submits new drug application to FDA for schizophrenia treatment

Karuna Therapeutics Inc. has submitted a new drug application to the FDA for KarXT, its investigational muscarinic antipsychotic for the treatment of schizophrenia.

According to a company press release, the NDA was supported by long-term safety and efficacy data of KarXT (xanomeline-trospium) from the EMERGENT series of clinical trials: the completed EMERGENT-1, EMERGENT-2 and EMERGENT-3 studies, which assessed safety and efficacy compared with placebo, and the ongoing EMERGENT-4 and EMERGENT-5 trials evaluating KarXT’s long-term safety profile.

Across all placebo-controlled trials, KarXT met its primary endpoint in demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared vs. placebo, while showing significant reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative and PANSS negative Marder factor subscales, per the release.

KarXT, which acts as a dual M1/M4 muscarinic acetylcholine receptor agonist, was also generally well-tolerated, with most adverse events being cholinergic in nature and mild to moderate in severity, according to Karuna. Discontinuation as a result of treatment-emergent adverse events was low, and KarXT was not linked with side effects seen with currently available antipsychotics, such as weight gain and somnolence.

“While current therapies have made a difference for many patients, they are not without limitations due to lack of full symptom relief or side effects that may lead to treatment discontinuation,” Bill Meury, Karuna’s president and CEO, said in the release. “KarXT, if approved, will represent the first novel pharmacological approach to treating schizophrenia in several decades and provide a new treatment option for patients and their physicians.”