BioCentury
ARTICLE | Clinical News

AVP-923: Completed Phase II enrollment

July 15, 2013 7:00 AM UTC

Avanir completed enrollment in the double-blind, placebo-controlled, international Phase II PRIME trial evaluating 45/10, 30/10 and 20/10 mg AVP-923 twice daily for 12 weeks. In February, the company said it would reduce target enrollment in PRIME to 200 from 400 MS patients based on data from a Phase I trial of AVP-786, a deuterium-containing analog of dextromethorphan, plus low-dose quinidine to treat pain. The Phase I data showed that AVP-786 plus low-dose quinidine had a comparable pharmacokinetic, safety and tolerability profile to AVP-923, which contains a higher dose of quinidine (10 mg) than that given with AVP-786. Avanir said data from PRIME would guide further development of AVP-786, which the company said has the "potential to be a preferable development compound" over dextromethorphan/quinidine in pain indications (see BioCentury, Feb. 18). ...