ALISO VIEJO, Calif.
, May 27, 2014
/PRNewswire/ -- Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced completion of patient enrollment in the company's phase II, placebo controlled study testing AVP-923 for the treatment of agitation in Alzheimer's disease patients. Top-line results from this study are expected late September/early October.
"Final completion of enrollment in this study is an important milestone for Avanir as we explore the therapeutic utility of AVP-923, and later AVP-786 for the management of neuropsychiatric manifestations of neurological disease, including agitation," said Joao Siffert, MD, chief medical officer at Avanir. "We are looking forward to the results from this study to potentially help guide the phase III development of AVP-786 for the treatment of agitation in patients with Alzheimer's disease. AVP-786 is our next generation investigational product containing deuterium modified dextromethorphan and ultra-low dose quinidine."
About the Study
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 multicenter, randomized, double-blind, placebo-controlled study that enrolled 220 Alzheimer's patients in the United States. Eligible patients were randomized to receive either AVP-923 (dose escalated from DM 20mg/ Q 10mg to DM 30mg/ Q 10mg) or placebo for 10 weeks. The main efficacy measure is the agitation/aggression subscale of the Neuropsychiatric Inventory or NPI. Secondary outcome measures include global assessments of disease severity, other neuropsychiatric symptoms, cognition, activities of daily living, quality of life and caregiver strain. Standard safety assessments will also be conducted.
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 FDA.
AVP-786 is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan and ultra-low dose quinidine, used as a metabolic 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. AVP-786 is an investigational drug not approved by the FDA.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.
©2014 Avanir Pharmaceuticals, Inc. All Rights Reserved.
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. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, including the risks and uncertainties associated with meeting the objectives of the study of AVP-786, and AVP-923, including, but not limited to, risks relating to the successful development of these investigational drugs, delays or failures in enrollment, or delays in the release of study results, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Avanir Investor & Media Contact
Ian Clements, PhD
+1 (949) 389-6700
Logo - http://photos.prnewswire.com/prnh/20130207/LA55901LOGO
SOURCE Avanir Pharmaceuticals, Inc.