NUEDEXTA substantially reduced PBA episode rates in a 12-week clinical trial as early as Week 1a,17

Pivotal trial: Mean weekly PBA episode decrease (%) from baseline

Pivotal trial: Mean weekly episode decrease (%) from baseline
Pivotal Trial Chart Data
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Complete episode remission was achieved by 51% of patients receiving NUEDEXTA vs 29% receiving placebob,32

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.32

49% cumulative PBA daily episode rate reduction over placebo over the course of the 12-week trial (P<0.001; primary endpoint)17

82% mean PBA episode reduction receiving NUEDEXTA in Week 12 vs 45% receiving placebo17

Download the full NUEDEXTA Pivotal Trial publication

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.
bRemission was a secondary outcome. Remission was defined as the absence of PBA episodes during the patient’s final 14 days of the 12-week study.32