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AVANIR Pharmaceuticals to Present Zenvia Phase III Data in Diabetic Peripheral Neuropathic Pain at Second International Congress on Neuropathic Pain.


Two Poster Presentations Scheduled for June 8 at 1:30 p.m. CET CET
abbr.
Central European Time


CET Central European Time

CET n abbr (= Central European Time) → hora de Europa central

CET abbr
 

ALISO VIEJO, Calif. -- AVANIR Pharmaceuticals (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AVNR AVNR Atrioventricular Nodal Reentry ) today announced Phase III data on the efficacy, safety and improvements in patient-centered outcomes in patients with diabetic peripheral neuropathic (DPN DPN, in biochemistry, abbreviation for diphosphopyridine nucleotide, a coenzyme now usually called nicotinamide adenine dinucleotide, or NAD.

DPN - Decomposed Petri Net
) pain treated with the investigational drug Zenvia[TM] (dextromethorphan / quinidine quinidine (kwĭn`ĭdēn'), heart muscle relaxant used to maintain regular heart rhythm patterns. It is an alkaloid chemically similar to quinine and, like quinine, occurs naturally in some species of cinchona trees. ) will be presented in two scientific posters at the Second International Congress on Neuropathic Pain, being held in Berlin, Germany on June 7 to 10, 2007.

Both posters will be presented at Poster Session 1: Clinical - Pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines.

phar·ma·co·ther·a·py
n.
Treatment of disease through the use of drugs.
 on Friday, June 8, 2007, between 1:30 p.m. and 3:30 p.m. Central European time Central European Time
Noun

the standard time adopted by Western European countries one hour ahead of Greenwich Mean Time, corresponding to British Summer Time Abbrev: (CET)
 (CET).

"This scientific congress serves as a showcase for new developments in pain treatment. We are pleased that these data have been recognized as important by the congress organizers and accepted for presentation," said Randall Kaye, MD, Chief Medical Officer of AVANIR Pharmaceuticals.

The accepted posters are:

* Poster number 1497: EFFICACY AND SAFETY OF DEXTROMETHORPHAN/QUINIDINE IN TREATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY Diabetic peripheral neuropathy
A condition where the sensitivity of nerves to pain, temperature, and pressure is dulled, particularly in the legs and feet.

Mentioned in: Diabetes Mellitus
: RESULTS OF A PHASE III, DOUBLE-BLIND, RANDOMIZED ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, PLACEBO-CONTROLLED TRIAL

* Poster number 1498: IMPROVED PATIENT-CENTERED OUTCOMES WITH DEXTROMETHORPHAN/QUINIDINE VS PLACEBO IN A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL INVESTIGATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY

On April 18, 2007 AVANIR Pharmaceuticals announced positive top-line results from a Phase III study of Zenvia in patients with DPN pain. In the trial, two doses of Zenvia, 45/30 mg DMQ DMQ Dead Message Queue (Sun Java Messaging Server)
DMQ Disquieting Muses Quarterly (webzine)
DMQ Doctor of Medical Qigong Therapy
DMQ DEC Message Queue
DMQ Deer Management Qualification
 dosed twice daily (DMQ 45) and 30/30 mg DMQ dosed twice daily (DMQ 30), were compared to placebo based on daily patient diary entries for the Pain Rating Scale, which was the primary endpoint as defined in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). Both Zenvia treatment groups had lower pain ratings than placebo patients (p [?]0.0001 in both cases). In this study, Zenvia also demonstrated statistically significant improvements in a number of key secondary endpoints including the Pain Relief Ratings Scale and the Pain Intensity Ratings Scale. Although not statistically powered to detect differences in the secondary endpoint of Peripheral Neuropathy Quality of Life Scale Composite score, the DMQ 45 patients showed a greater improvement than placebo patients (p=0.05) and the DMQ 30 patients showed a greater improvement than placebo patients (p=0.08). Overall, the safety data from this study were consistent with data from previous studies. The most commonly reported adverse events were dizziness, nausea, diarrhea, fatigue and somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess.

som·no·lence
n.
1. A state of drowsiness; sleepiness.

2.
 and were mild to moderate in nature. A higher number of patients in the DMQ 45 and DMQ 30 treatment groups (25.2% and 21.0%, respectively) discontinued due to an adverse event than compared to placebo (11.4%). There were no significant differences in serious adverse events with 7.6%, 4.8% and 4.1% reported in the DMQ 45, DMQ 30 and placebo groups, respectively and no deaths occurred during the study.

About Zenvia

Zenvia is a combination of two well-characterized compounds, the therapeutically active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
 of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory ex·ci·ta·tive   or ex·ci·ta·to·ry
adj.
Causing or tending to cause excitation.

Adj. 1. excitatory - (of drugs e.g.
 neurotransmission in two ways, through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic postsynaptic /post·sy·nap·tic/ (-si-nap´tik) distal to or occurring beyond a synapse.

post·syn·ap·tic
adj.
Situated behind or occurring after a synapse.
 glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of Involuntary Emotional Expression Disorder (IEED IEED Involuntary Emotional Expression Disorder ) and DPN pain.

In October 2006, the Company received an approvable letter for the treatment of Zenvia in IEED. To address safety concerns raised in the FDA's approvable letter for Zenvia for the treatment of IEED, the company intends to initiate a confirmatory Phase III study with a new lower quinidine dose formulation of Zenvia. In April 2007 AVANIR completed the first of two planned Phase III studies in diabetic peripheral neuropathic pain where all primary endpoints were successfully met. The Company is considering whether it would be necessary or advisable to study a similar lower dose of quinidine in the second Phase III trial being planned for DPN pain.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo([R]), the only orally-disintegrating formulation of clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia.

clo·za·pine
n.
 for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatments for schizophrenia. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com, AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), Zenvia, is the subject of an approvable letter from the FDA. Additionally, AVANIR recently completed a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  with Zenvia in patients with diabetic peripheral neuropathic (DPN) pain where all primary endpoints were met. AVANIR has an ongoing development program with Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. The Company's first commercialized product, Abreva([R]), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.

Forward-Looking Statement

Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. There can be no assurance that the Company will receive FDA regulatory approval for Zenvia or that the additional development work for Zenvia will be completed in the time periods that are anticipated. Final review decisions made by the FDA and other regulatory agencies concerning are often unpredictable and outside the influence and control of the Company. Risks and uncertainties also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.

To be included on AVANIR's e-mail alert list; click on the link below or visit AVANIR's website: http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0
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Publication:Business Wire
Date:May 8, 2007
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