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# Karuna Mid-Year NDA Planned for Schizophrenia Drug
- URL: https://www.fdaweb.com/karuna-mid-year-nda-planned-for-schizophrenia-drug/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:20:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154030

Karuna Therapeutics is planning a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from its Phase 3 EMERGENT-3 trial evaluating the drug's (XXXX INSERT XXX)efficacy, safety (XXX DELETE COMMA XXXX)and tolerability. (XXXX DELETE XXX)

“The trial met its primary endpoint,” the company says, “with KarXT demonstrating a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-20.6 KarXT vs. -12.2 placebo; p<0.0001) at Week 5… Consistent with prior trials, KarXT demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 (p<0.05) through the end of the trial as assessed by PANSS total score.”

Regarding safety, Karuna says KarXT has a side effect profile substantially consistent with previous trials. “The overall discontinuation rate in the trial was 33% (37% KarXT vs. 29% placebo),” it says. “The overall treatment emergent adverse event (TEAE) rates for KarXT and placebo were 70% and 50%, respectively. Discontinuation rates related to TEAEs were similar between treatment arms (6% KarXT vs. 5% placebo), consistent with the EMERGENT-1 and EMERGENT-2 trials. The only serious TEAE reported in the KarXT arm was related to gastroesophageal reflux disease (acid reflux) and deemed not to be related to the study drug.”