Navigation Links
Avanir Pharmaceuticals Announces Publication of Phase III Study Results Showing Efficacy and Safety of AVP-923 in the Treatment of Diabetic Neuropathic Pain
Date:2/8/2012

ALISO VIEJO, Calif., Feb. 8, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that the results of the study entitled "Efficacy and Safety of Dextromethorphan/Quinidine (AVP-923) at Two Dosage Levels for Diabetic Neuropathic Pain: A Double-Blind, Placebo-Controlled, Multicenter Study" have been published in the February edition of the journal Pain Medicine.

"Throughout a 13-week trial, AVP-923 was effective, with an acceptable safety profile, for treatment of diabetic peripheral neuropathic pain. The findings indicate that other fixed-dose combinations of AVP-923 should be studied to improve overall tolerability while maintaining significant efficacy," said Aziz Shabaini, MD, Medical Director of the Nerve and Muscle Center, Texas.

AVP-923 is a combination of dextromethorphan (DM) and quinidine (Q). AVP-923 is currently being studied in a Phase II clinical trial (the PRIME study) in central neuropathic pain in patients with multiple sclerosis.

"Today's publication in a leading peer-review medical journal complements a body of scientific literature suggesting that dextromethorphan could be efficacious in neuropathic pain," said Joao Siffert, MD, senior vice president of research and development at Avanir. "These results provide additional rationale in support of the ongoing PRIME study, which is evaluating the combination of dextromethorphan and quinidine in central neuropathic pain in patients with multiple sclerosis."

Study Design

In a 13-week, phase III, randomized, controlled trial, 379 adults with daily symmetric diabetic peripheral neuropathy (DPN) leg pain for >3 months received double-blind placebo, DMQ 45/30 mg, or DMQ 30/30 mg, administered once daily for 7 days and twice daily thereafter. Efficacy measures included four pain rating scales applied daily using patient diaries, and another two applied at five clinic visits.  Safety and tolerability were assessed by adverse event reports, physical examination, electrocardiogram and clinical laboratory tests. Patients with certain cardiac conditions were excluded from the study along with patients taking certain medications.

Study Results

On all six scales, DMQ 45/30 mg was significantly superior to placebo, including the primary efficacy analysis, which utilized mixed-effects modeling to test all scores on an 11-point numerical Pain Rating Scale (p < 0.0001). Sensitivity analyses gave consistent results. Efficacy versus placebo was also seen for diary ratings of present pain intensity, and pain interference with sleep and with activities (all p < 0.0001). Among clinic-visit assessments, DMQ 45/30 mg demonstrated greater leg-pain relief (p = 0.0002) and greater reduction of leg-pain intensity (p = 0.0286) versus placebo. The efficacy of DMQ 30/30 mg was numerically less than for 45/30 mg but for most outcomes remained significantly greater versus placebo. Adverse events were mostly mild or moderate and of expected types. Discontinuation for adverse events in the DMQ groups was at least twice as common as placebo.

About Diabetic Peripheral Neuropathic Pain

Diabetic neuropathic pain, one of the most debilitating forms of pain, is caused by nerve damage that can result from diabetes. It is often described as burning, tingling, stabbing, or pins and needles in the feet, legs, hands or arms. The most frequent form, estimated to affect approximately 50% of diabetic patients, is a distal symmetric polyneuropathy that can involve both small and large sensory fibers. The associated pain, estimated to affect approximately 25% of DPN patients, can be severe and disabling.

About AVP-923

AVP-923 is a combination of two well-characterized compounds: the active ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) and low dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is an investigational drug and is not approved for the treatment of diabetic peripheral neuropathic pain.

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® and NUEDEXTA® are registered trademarks owned by Avanir Pharmaceuticals, Inc.

©2012 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 Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new 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
ir@avanir.com
+1 (949) 389-6700


'/>"/>
SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Avanir Pharmaceuticals Reports Fiscal 2011 Fourth Quarter and Year End Financial Results
2. Avanir Pharmaceuticals Announces Date of Fiscal 2011 Fourth Quarter and Year End Financial Results and Conference Call
3. Avanir Pharmaceuticals to Participate in Piper Jaffray Health Care Conference
4. Avanir Pharmaceuticals Announces EMA Acceptance of Marketing Authorization Application for NUEDEXTA
5. Avanir Pharmaceuticals Submits European Marketing Authorization Application for NUEDEXTA
6. Avanir Pharmaceuticals to Present Data at the 2011 American Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine Annual Conference
7. Avanir Pharmaceuticals to Participate in Two Investor Conferences
8. Avanir Pharmaceuticals to Present at Stifel Nicolaus Healthcare Conference
9. Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents
10. Avanir Pharmaceuticals Reports Fiscal 2011 Third Quarter Financial Results
11. Avanir Pharmaceuticals Announces Appointment of Dr. Joao Siffert as Senior Vice President Research and Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016  Kindred ... focused on saving and improving the lives of pets, ... Technical Section of the New Animal Drug Application (NADA) ... the pivotal field study (KB0120) of Zimeta for the ... by the Company. --> ...
(Date:2/11/2016)... N.Y. , Feb. 11, 2016  Governor Andrew ... that will create 1,400 jobs throughout Western ... a partnership with the SUNY Polytechnic Institute, includes a ... Conventus Building in Buffalo , as ... foot manufacturing facility in Dunkirk . ...
(Date:2/11/2016)... 11, 2016 Potrero Medical, Inc., the developer of ... the appointment of George M. Rapier, III , MD, ... TX , WellMed is one of the nation,s largest ... HMO members in Texas and ... of his own internal medicine practice, he has been instrumental ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... A lot has been reported about the fitness ... access to health and wellness resources most Americans could ever dream of having at ... a schedule as frenetic as the U.S. President. , In honor of President’s ...
(Date:2/12/2016)... ... ... The Central Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to its annual Winter ... teens with and without special needs to gather in a safe and supportive environment. Volunteers ... will take place on Saturday, Feb. 13 from 7 to 9:30 p.m. at Elks Lodge, ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Yisrayl Hawkins, Pastor ... article this week that uncovers what he says are the real facts surrounding all ... the Bible from parents and Sunday school teachers, and Yisrayl says there is more ...
(Date:2/12/2016)... ... February 12, 2016 , ... Planet Future ... new cartoon style themes are great for showcasing pictures, videos as well as text ... titles like introductions, lower thirds, transitions and a beautiful frame overlay. Pixel Film Studios ...
(Date:2/12/2016)... ... ... Dignity Health named Dr. Scott Bingham the Facility Medical Director of the ... licensed under Dignity Health Arizona General Hospital , which opened last year in ... our new freestanding emergency room delivers the highest quality care to Mesa and the ...
Breaking Medicine News(10 mins):