NUEDEXTA is the first and only FDA-approved treatment for Pseudobulbar Affect (PBA)1
NUEDEXTA is clinically proven to reduce PBA episodes and has a demonstrated safety profile.1,3,5
PBA causes uncontrollable laughing and/or crying that happens suddenly. Because episodes are unpredictable, many patients worry about having an episode in public — and they may feel uncomfortable in social settings. But the disorder is manageable and NUEDEXTA can help reduce their daily episodes.1,2
Reducing PBA episodes can make a difference.
For patients with PBA, each episode can have an impact. In one web-based survey (N=1,052) of patients with an underlying neurologic condition associated with PBA or their nonpaid caregivers, respondents who described their uncontrollable laughing and/or crying episodes as “extremely” or “very” burdensome had experienced an average of 8.8 crying episodes or 4.6 laughing episodes in the past week.8 Patients with PBA symptoms (N=399) were defined as those who scored 13 or greater on the Center for Neurologic Study-Lability Scale (CNS-LS).*
*The CNS-LS was validated as a measure of perceived episode frequency in amyotrophic lateral sclerosis and multiple sclerosis populations. The scale does not confer a PBA diagnosis.6,7
A Real Patient’s Treatment Story
Learn about the impact of reducing PBA episodes with NUEDEXTA.
NUEDEXTA’s Safety And Efficacy Were Evaluated In Two Clinical Trials
The STAR Pivotal trial was a phase 3, double-blind, placebo-controlled study (N=326) in patients with PBA secondary to amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).3
NUEDEXTA significantly reduced PBA episode rates compared with placebo in the 12-week Pivotal trial5
- At Week 12, patients on NUEDEXTA experienced a 3.9 mean reduction in the daily PBA episode rate (6.8 baseline) versus a 3.0 mean reduction (4.5 baseline) for those on placebo (P=0.005).1,3
- In a post-hoc analysis, NUEDEXTA significantly reduced PBA episodes rates compared to placebo starting at Week 1.
- Complete PBA episode remission was achieved by 51% of patients on NUEDEXTA versus 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.
- The most common adverse effects were diarrhea and dizziness.1,3
The PRISM II study was a phase 4, open-label study (N=367) 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 TBI.5
- 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
- Overall, patients started with about 12 episodes per week at baseline and 2 by Week 12.4
- The most common adverse effects were diarrhea and headache.1,4
Safety and Efficacy Pocket Guide
Keep NUEDEXTA’s safety and efficacy profile handy with a pocket guide. Download Now
NUEDEXTA is the first and only FDA-approved treatment for PBA.1 Explore the pages below to learn more about treating PBA with NUEDEXTA.