Table 2.
Key findings on the effects based on the positive and negative syndrome scale scores from completed 5-week clinical trials
| Variable |
EMERGENT-1[43]
|
EMERGENT-2[14]
|
EMERGENT-3[47]
|
|||
|
KarXT vs placebo
|
P value
|
KarXT vs placebo
|
P value
|
KarXT vs placebo
|
P value
|
|
| Number of patients (modified intention-to-treat population) | 83 vs 87 | - | 117 vs 119 | - | 114 vs 120 | - |
| Least-squares mean change from baseline in PANSS total score (points) | -17.4 vs -5.9 | < 0.001 | -21.2 vs -11.6 | < 0.0001 | -20.6 vs -12.2 | < 0.0001 |
| Least-squares mean change from baseline in PANSS positive symptom subscore (points) | -5.6 vs -2.4 | < 0.001 | -6.8 vs -3.9 | < 0.0001 | -7.1 vs -3.6 | < 0.0001 |
| Least-squares mean change from baseline in PANSS negative symptom subscore (points) | -3.2 vs -0.9 | < 0.001 | -3.4 vs -1.6 | 0.0055 | -2.7 vs -1.8 | 0.1224 |
| Least-squares mean change from baseline in PANSS Marder negative symptom subscore (points) | -3.9 vs -1.3 | < 0.001 | -4.2 vs -2.0 | 0.0022 | -3.5 vs -2.7 | 0.1957 |
Studies included patients aged 18-60 years (EMERGENT-1) or up to 65 years (EMERGENT-2 and EMERGENT-3) with a primary diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition, experiencing an acute exacerbation or relapse of psychosis requiring hospitalization with onset within 2 months before screening. Participants were required to be free of antipsychotic medication for a specified period before the baseline assessment: In EMERGENT-1, at least two weeks for oral antipsychotics or 1.5 injection cycles for long-acting injectables (LAI); and in EMERGENT-2 and EMERGENT-3, at least five half-lives or one week (whichever was longer) for oral antipsychotics, or at least 12 weeks for LAI (24 weeks for paliperidone palmitate). KarXT: Xanomeline/trospium chloride; PANSS: Positive and Negative Syndrome Scale.