Schizophrenia drug demonstrates efficacy, tolerability in phase 3 trial

Key takeaways:

• A phase 3 trial of xanomeline-trospium for schizophrenia yielded positive efficacy and tolerability results.
• The findings support an upcoming FDA new drug application by Karuna Therapeutics for the drug.

KarXT was efficacious and safe in and well-tolerated by people with schizophrenia, according to a press release from its manufacturer.

The findings come from the phase 3 EMERGENT-3 trial of KarXT (xanomeline-trospium, Karuna Therapeutics). Compared with participants taking placebo, participants taking KarXT experienced significant improvements in Positive and Negative Syndrome Scale (PANSS) total score (–12.2 vs. –20.6; P < .0001) and PANSS positive subscale (–3.6 vs. –7.1; P < .0001) after 5 weeks of treatment.

Treatment-emergent adverse events occurred in 70% of participants taking KarXT and 50% of participants taking placebo, with similar adverse event-related discontinuation rates (6% vs. 5%, respectively). The most common treatment-emergent adverse events in participants taking KarXT were nausea, dyspepsia, vomiting, constipation, headache, hypertension, diarrhea and insomnia. These were all mild or moderate in severity, according to the release.

“KarXT has now demonstrated a robust and consistent reduction of symptoms across all three registrational trials, providing a compelling picture of the potential of KarXT in schizophrenia,” Bill Meury, president and CEO of Karuna Therapeutics, said in the release. “With these data, we are one step closer to a potential treatment option that could provide the first new mechanism of action to treat schizophrenia in several decades.”

With positive findings from this and previous trials, Karuna Therapeutics aims to submit a new drug application for KarXT to the FDA by mid-2023. If approved, the drug may launch in the second half of 2024, according to the release.