Avanir Pharmaceuticals Provides "Several Positive Developments" on European Regulatory Filing for NUEDEXTA

Avanir Pharmaceuticals, Inc. AVNR today announced several positive developments regarding its anticipated European regulatory filing of NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules for the treatment of pseudobulbar affect. On July 22, 2011, company officials met with the European Medicines Agency to discuss plans for filing a marketing authorization application for NUEDEXTA for the treatment of PBA. Based on the outcome of the meeting, the company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA. The timing of the company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan (PIP) for NUEDEXTA which may occur before the end of calendar year 2011. In addition, the company also received notification from the EMA that NUEDEXTA can be filed for approval under the agency's centralized procedure. Filing under the centralized procedure provides for a single, coordinated review that is conducted by the EMA and results in a regulatory decision which is binding on all European Union member states. Centrally-authorized products may be marketed in all member states. "PBA is a disabling neurologic condition affecting the lives of many people in Europe," said Professor Kevin Talbot, MBBS, DPhil, FRCP, Senior Clinical Lecturer in the Department of Clinical Neurology, and Director of the Motor Neuron Disease Care and Research Centre at University of Oxford. "As more resources are committed to understanding PBA in Europe, its prevalence and the importance of treating this disorder will be better appreciated. Meeting with the EMA is an important next step toward making a proven treatment like NUEDEXTA available to patients with this debilitating disorder."