Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder
"The endorsement of this Phase II study by the division of Psychiatry Products at the
The filing of this IND represents the first step in Avanir's plan to develop AVP-786 for a broad array of neurological and psychiatric conditions.
About the Study
This multicenter, randomized, double-blind, placebo-controlled proof-of-concept Phase II study will evaluate the efficacy and safety of AVP-786 in patients suffering from MDD 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 in
About Major Depressive Disorder
Major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 16.1 million people in the U.S. suffer from MDD in a given year, with as many as two-thirds of patients who are diagnosed with MDD do not experience adequate improvement with initial antidepressant therapy.
AVP-786, the company's next-generation AVP-923 compound, is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) and ultra-low dose quinidine (a CYP2D6 enzyme inhibitor). Incorporation of deuterium into specific positions of the dextromethorphan molecule strengthens the chemical bonds and reduces susceptibility to enzyme cleavage and first pass metabolism, but without altering its pharmacology. By decreasing the metabolism rate, AVP-786 requires a substantially lower level of the metabolic inhibitor quinidine. This may result in a reduced potential for drug interactions, while maintaining its therapeutic efficacy. AVP-786 is an investigational drug not approved by the
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer's disease, levodopa-induced dyskinesia in Parkinson's disease, and multiple investigator initiated studies. AVP-923 is an investigational drug not approved by the
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Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements relating to the relative benefits of AVP-786, the timing for an approval decision from the
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