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Avanir Pharmaceuticals Announces Initiation of Phase II Study of AVP-786 for the Adjunctive Treatment of Major Depressive Disorder
Date:8/26/2014

gly utilized in central nervous system (CNS) clinical trials. This study design is intended to reduce placebo response rates, a phenomenon commonly observed in depression trials.  The primary efficacy measure is the Montgomery-Asberg Depression Rating Scale (MADRS) total score, a standard clinical measure of depression. Secondary outcome measures include assessments of disease severity, activities of daily living, and quality of life. Pharmacokinetics and standard safety assessments will also be conducted.

Update on the Agitation in Alzheimer's Disease Patients Study
The company expects to announce top-line results from the Agitation in Alzheimer's disease study in late September/early October 2014. The objectives of this proof of concept study are to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of agitation in Alzheimer's patients. The trial is a 10-week, multicenter, randomized, double-blind, placebo-controlled study utilizing a SPCD design intended to reduce placebo response rates. Enrollment was completed with 220 Alzheimer's patients in the United States. Eligible patients were initially randomized 3:4 to receive either AVP-923 (dose escalated from DM 20mg/ Q 10mg to DM 30mg/ Q 10mg) or placebo. At the end of week five, patients who initially received placebo were stratified according to their response to treatment and subsequently re-randomized 1:1 to receive either AVP-923 or placebo for the remainder of the study (an additional 5 weeks of treatment). Patients who initially received AVP-923 continued to receive AVP-923 DM 30mg/ Q 10mg for the remainder of the study. The main efficacy measure is the agitation/aggression subscale of the Neuropsychiatric Inventory or NPI. The primary endpoint follows a standard analysis of SPCD by combining the change from baseline to week 5 (full analysis population) and change from week 5 to week 10 on the NPI agitation/aggression domain (patients who we
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SOURCE Avanir Pharmaceuticals, Inc.
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