The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' 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.
The company plans to begin a Phase II proof of concept study of AVP-923 during the third calendar quarter of 2012.
Avanir Pharmaceuticals R&D senior vice president Joao Siffert said this marks the fourth IND for the AVP-923 program, reflecting the company's belief that the dual sigma-1 and NMDA receptor pharmacology has significant potential.
"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," Siffert added.
The study will evaluate the safety, tolerability and efficacy of AVP-923 for treatment of agitation and other behavioral disturbances in Alzheimer's patients.
The multicenter, randomized, double-blind, placebo-controlled study is expected to enroll approximately 200 Alzheimer's patients in the US.
The Neuropsychiatric Inventory scale or NPI is the main efficacy measure.
Measures of disease severity, cognition, activities of daily living, quality of life and caregiver strain are the secondary outcome measures.
