FDA accepts Avanir IND for AVP-923 to treat agitation in patients with AD

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease (AD). The company plans to initiate a Phase II study evaluating AVP-923 during the third calendar quarter of 2012.

"This marks the fourth IND for the AVP-923 program, reflecting our belief that the unique dual sigma-1 and NMDA receptor pharmacology has significant potential," said Joao Siffert, MD, senior vice president of R&D at Avanir Pharmaceuticals. "With no approved treatments for agitation in patients with Alzheimer's disease, this remains an area of tremendous unmet medical need. We look forward to initiating our clinical research program later this year."