Reduction in median PBA episode counta,17
aMedian episode count is depicted as it is resistant to outliers, unlike the mean.
Mean (SD) CNS-LS reduction from baseline to Day 90
| Condition | Mean CNS-LS reduction | From baseline | To end of study |
|---|---|---|---|
| Dementia (n=102) | -7.2 (.06) | (20.1) | (13.0) |
| Stroke (n=92) | -7.6 (0.7) | (20.7) | (13.1) |
| TBI (n=67) | -8.5 (0.6) | (20.5) | (11.9) |
aCNS-LS is significant at P<0.001 compared to baseline.21
Global Improvement and Satisfaction Ratings at Day 90 (secondary outcomes)a,21
PGICc
72.4%
of patients were Much Improved or Very Much Improved with respect
to PBAb
CGICc
76.6%
of patients as rated by
their clinician were Much Improved or Very Much Improved with respect
to PBAb
SATISFACTIONd
75.5%
of patients were Somewhat Satisfied or Very Satisfied with NUEDEXTAb
% of patients (n=261)
These scales are subjective measures and may be subject to bias
particularly in the context of an open-label study.
aRatings measured at Day 90/Final Visit.21
bCaregivers completed the rating when the patient was not able to do so.21
cUsing the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) scales, patients/clinicians were asked, “Rate the total impression of change in your/your patient’s condition (with respect to PBA) from the time of study admission to the present (end of study).” PGIC reported: 32.6% Very Much Improved; 39.8% Much Improved; 18.8% Minimally Improved; 8% No Change; 0.4% Minimally Worse; 0.4% Much Worse. CGIC reported: 33.7% Very Much Improved; 42.9% Much Improved; 13.4% Minimally Improved; 8.8% No Change; 0.8% Minimally Worse; 0.4% Much Worse. No patients/clinicians reported Very Much Worse.21
dPatients/caregivers were asked, “How satisfied are you with NUEDEXTA as a treatment for your PBA?” Reported: 47.5% Very Satisfied; 28% Somewhat Satisfied; 11.5% Neither Satisfied nor Dissatisfied; 5.4% Somewhat Dissatisfied; 7.7% Very Dissatisfied.21
90-day open-label (uncontrolled) Avanir-sponsored, US trial in adult patients with dementia, stroke, or TBI. All patients had a clinical diagnosis of PBA and a CNS-LS score of ≥13 at baseline. All patients received NUEDEXTA twice-daily (once-daily in Week 1) in accordance with approved labeling. The primary endpoint was change from baseline to Day 90/Final Visit CNS-LS score for the effectiveness population (all patients on NUEDEXTA with 1 post-baseline CNS-LS score and who met study inclusion/exclusion criteria).
