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Poster
1586214
Safety and Efficacy of KarXT in Schizophrenia in the Randomized, Double-Blind, Placebo-Controlled, Phase 3 EMERGENT-3 Trial
Psych Congress 2023
This work was sponsored by Karuna Therapeutics
KarXT combines the dual M1/M4 preferring muscarinic receptor agonist xanomeline and the peripherally restricted muscarinic receptor antagonist trospium. KarXT is designed to preserve xanomeline’s beneficial CNS effects while ameliorating peripheral side effects. In the EMERGENT-1 and EMERGENT-2 trials KarXT met the primary endpoint and secondary outcomes measures and was generally well tolerated.
EMERGENT-3 (NCT04738123) was a 5-week, randomized, double-blind, placebo-controlled phase 3 trial of KarXT in people with schizophrenia with acute psychosis. Participants were randomized 1:1 to KarXT or placebo. KarXT dosing started at 50 mg/20 mg BID and increased to a maximum of 125 mg/30 mg BID. Primary endpoint: change in PANSS total score from baseline to week 5. Secondary outcomes included PANSS subscale changes, CGI-S scores, and proportion of participants with ≥30% reduction in PANSS total score.
256 people were enrolled. KarXT significantly reduced PANSS total score compared with placebo (KarXT: -20.6; placebo: -12.2, P
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