Nuedexta dextromethorphan/quinidine: Phase II data
The 10-week, double-blind, U.S. Phase II AVR-131 trial in 220 AD patients showed that oral 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). AVP-923 also met the secondary endpoints of improving NPI total score (p=0.014), CGIC-agitation (p=0.0003), Patient Global Impression of Change (PGIC) (p=0.001) and measures of caregiver burden (p<=0.05) vs. placebo. AVP-923 was generally well tolerated with falls, diarrhea and urinary tract infection reported as the most common adverse events.
The trial utilized a sequential parallel comparison design (SPCD) intended to reduce placebo response rates. 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. At the end of week 5, patients who initially received placebo were stratified according to their response and subsequently 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. Data will be presented at the American Neurological Association meeting in Baltimore in October. Avanir said it plans to meet with FDA and EMA to discuss plans for pivotal trials of AVP-923. ...