AVANIR Granted Special Protocol Assessment (SPA) From FDA for Confirmatory Phase III Trial of Zenvia in Patients With PBA (Business Wire)
By etrader on October 8, 2007 at 5:29 am in Online Trading
ALISO VIEJO, Calif.—-AVANIR Pharmaceuticals today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration , under the Special Protocol Assessment process, on the design of a single confirmatory Phase III clinical trial of Zenvia (dextromethorphan/quinidine ) for the treatment of patients with pseudobulbar affect .
More: continued here
