NUEDEXTA substantially reduced PBA episode rates as early as Week 1a,1

In the pivotal trial, the primary endpoint of laughing and crying episodes was statistically significantly lower with NUEDEXTA than with placebo2

  • At Week 12, patients on NUEDEXTA experienced a PBA episode reduction of -3.9 from a 6.8 baseline vs a -3.0 reduction from a 4.5 baseline for placebo (P=0.005 vs placebo)
  • 49% incremental reduction in PBA episode rate at Week 12 was demonstrated with NUEDEXTA vs placebo (P<0.0001, predefined primary efficacy analysis)

82% mean PBA episode reduction in patients receiving NUEDEXTA at Week 12 vs 45% receiving placebo1

EPISODE RATE REDUCTION FROM BASELINE IN THE POST-HOC ANALYSIS OF THE 12-WEEK PIVOTAL TRIAL1

Pivotal trial: Mean weekly episode decrease (%) from baseline
Pivotal Trial Chart Data
 
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  • The secondary endpoint, CNS-LS score, a 7-item self-assessment of PBA frequency and severity, was also significantly lower at Week 121
Study Description
 

12-week, randomized, placebo-controlled study in 326 patients with ALS (n=197) or MS (n=129) and clinically significant PBA. Patients received NUEDEXTA (n=107), placebo (n=109), or dextromethorphan 30 mg/quinidine 10 mg (n=110 [unapproved dose, not shown]) twice daily (once daily in Week 1). Mean weekly episode rate reduction was a post-hoc analysis of the primary endpoint.2

Complete episode remission was achieved by more patients on NUEDEXTA than on placebo (51% vs 29%). Remission was a secondary outcome, defined as the absence of PBA episodes during the patient’s final 14 days of the 12-week study2

aStudy was performed in 326 patients with ALS or MS and clinically significant PBA. Patients received NUEDEXTA, placebo, or dextromethorphan 30 mg/quinidine 10 mg (DM/Q 30 mg/10 mg) twice daily (once daily in Week 1). DM/Q 30 mg/10mg is not an FDA-approved dose and results are not shown.2