ALISO VIEJO, Calif.--(BUSINESS WIRE)--AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial of Zenvia™ (dextromethorphan/quinidine [DM/Q]) for the treatment of patients with pseudobulbar affect (PBA). AVANIR trial 07-AVR-123 “A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients with Amyotrophic Lateral Sclerosis and Multiple Sclerosis” (otherwise known as the “STAR trial”) is expected to begin enrolling patients by the end of 2007.
