Nuedexta dextromethorphan/quinidine: Additional Phase II data

Additional data from 218 AD patients in the modified intent-to-treat (mITT) population of the 10-week, double-blind, U.S. Phase II AVR-131 trial showed that oral AVP-923 significantly reduced agitation as measured by the agitation/aggression subscale score of the NPI from baseline to week 5 vs. placebo (3.3 vs. 1.7 points, p=0.0002) in stage 1 of the trial (n=218). AVP-923 also significantly reduced the agitation/aggression subscale score of the NPI from week 5 to week 10 vs. placebo (2 vs. 0.8 points, p=0.021) in stage 2 of the trial (n=89). Data were presented at the American Neurological Association meeting in Baltimore.

The trial utilized a sequential parallel comparison design (SPCD) intended to reduce placebo response rates. In stage 1, patients in the AVP-923 arm received once-daily 20/10 mg for 7 days followed by twice-daily 20/10 mg for 14 days and twice-daily 30/10 mg thereafter. In stage 2, patients who initially received placebo and did not respond at the end of week 5 were re-randomized to receive AVP-923 or placebo for an additional 5 weeks. Patients who initially received AVP-923 continued AVP-923 treatment for the remainder of the study. The primary endpoint combined the change from baseline to week 5 in stage 1 and the change from week 5 to week 10 in stage 2. Avanir previously reported that AVP-923 met the primary endpoint of reducing agitation as measured by the agitation/aggression subscale score of the NPI vs. placebo (p=0.00008) (see BioCentury, Sept. 22). Avanir said it plans to meet with FDA and EMA to discuss plans for pivotal trials of AVP-923. ...