Nuedexta dextromethorphan/quinidine: Phase IV data

Top-line data from the open-label, U.S. Phase IV PRISM II trial in 367 patients with PBA showed that twice-daily 20/10 mg Nuedexta reduced mean CNS-LS score to 11.9 points at week 12 from 20.5 points at baseline in the cohort of patients with TBI (n=120) (p<0.001). Additionally, Nuedexta reduced overall weekly PBA episodes by 78.5% at week 12 compared to baseline (p<0.001). Furthermore, 73% of patients or caregivers rated themselves/the patient as being much/very much improved on the PGI-C and 78% of clinicians rated the patient to be much/very much improved on the CGI-C.

In the stroke cohort (n=113), Nuedexta reduced mean CNS-LS score to 13.1 points at week 12 from 20.8 points at baseline (p<0.001). Additionally, Nuedexta reduced overall weekly PBA episodes by 75.5% at week 12 compared to baseline (p<0.001). Furthermore, 68% of patients or caregivers rated themselves/the patient as being much/very much improved on the PGI-C and 75% of clinicians rated the patient to be much/very much improved on the CGI-C. ...