NUEDEXTA is the only FDA-approved, clinically proven treatment for PBA1

Pseudobulbar affect (PBA) causes uncontrollable laughing and/or crying that happens suddenly and is unpredictable. As a result, many patients worry about having an episode in public—and they feel uncomfortable in social settings. But the disorder is manageable and NUEDEXTA can help.1,2
The efficacy and safety of NUEDEXTA were evaluated in two clinical trials1,3,4

Phase 3, double-blind, placebo-controlled study in patients with PBA secondary to amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS)3
NUEDEXTA significantly reduced PBA episode rates compared with placebo at Week 1 and throughout the 12-week pivotal trial5
- At Week 12, -3.9 mean change in daily PBA episode rate (6.8 baseline) vs -3.0 (4.5 baseline) for placebo (P=0.005)1,3
- Complete PBA episode remission was achieved by 51% of patients on NUEDEXTA vs 29% on placebo by Week 12 (P<0.005)3
- Remission was a secondary outcome, defined as the absence of PBA episodes during the patient's final 14 days of participation in the 12-week study

Phase 4, open-label study in patients with PBA secondary to stroke, dementia, or traumatic brain injury (TBI)4
NUEDEXTA reduced PBA symptom scores and episode rates in patients with stroke, dementia, and TBI5
- At Day 90 of the PRISM II study, patients’ mean Center for Neurologic Study-Lability Scale (CNS-LS) score decreased by 7.7 points from 20.4 at baseline (P<0.001)4

Adverse events were generally consistent across clinical trials and mild to moderate in nature1,4
Patients describe PBA treatment in their own words
These short videos of real patients reveal how treatment with NUEDEXTA helped reduce their PBA episodes.

Titrate from 1 capsule once daily to 1 capsule every 12 hours on Day 8.1 Efficacy beyond Week 1 in the pivotal trial was achieved with Q12H dosing.5
- Following this regimen, patients on NUEDEXTA had a mean 82% reduction in PBA episodes vs 45% on placebo at 12 weeks in the STAR pivotal trial5
- The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA symptoms occurs in some patients