PBA episode reduction in different neurologic conditions with NUEDEXTA

Reduction in median PBA episode counta,17

OPen Label Efficac

 

aMedian episode count is depicted as it is resistant to outliers, unlike the mean.

Significant reduction in CNS-LS scores across all 3 conditions with NUEDEXTA (primary endpoint)a,21

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

 
72.4% of patients (based on PGIC) reported Much/Very Much Improved with respect to PBA

PGICc

72.4%

of patients were Much Improved or Very Much Improved with respect to PBAb

76.6% of patients as rated by their clinician (based on CGIC) reported Much/Very Much Improved with respect to PBA

CGICc

76.6%

of patients as rated by their clinician were Much Improved or Very Much Improved with respect to PBAb

75.5% of patientsd reported Somewhat/Very Satisfied with NUEDEXTA

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

 

Study Description
 

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).