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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

ALISO VIEJO, Calif., Aug. 26, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the enrollment of the first patient into a phase II study to evaluate the efficacy, safety and tolerability of AVP-786 for the adjunctive treatment of major depressive disorder (MDD). AVP-786 is a novel investigational drug consisting of a combination of deuterium modified dextromethorphan and ultra-low dose quinidine.

"There are millions of people with MDD who remain depressed despite receiving standard antidepressant therapy," said Maurizio Fava, MD, executive vice chair, department of psychiatry at Massachusetts General Hospital, Boston. "This is an important clinical study given the properties of AVP-786 and the vast unmet need in this area."

"With a unique, multifaceted mechanism of action encompassing key neurotransmitter systems involved in regulation of mood, AVP-786 has the potential to offer a new approach for the treatment of patients with depression," said Joao Siffert, MD, chief medical officer at Avanir Pharmaceuticals.

About the MDD Study
This 10-week, multicenter, randomized, double-blind, placebo-controlled proof-of-concept phase II study will evaluate the efficacy and safety of AVP-786 in patients with major depression who have had an inadequate response to commonly prescribed antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The study is expected to enroll approximately 200 patients at approximately 30 sites in the United States. The study will utilize a sequential parallel comparison design (SPCD); a design developed ten years ago by Drs. Fava and Schoenfeld at Massachusetts General Hospital and now increasin
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SOURCE Avanir Pharmaceuticals, Inc.
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