AVANIR Pharmaceuticals to Present Zenvia Phase III Data in Diabetic Peripheral Neuropathic Pain at Second International Congress on Neuropathic Pain
Both posters will be presented at Poster Session 1: Clinical - Pharmacotherapy on Friday, June 8, 2007, between 1:30 p.m. and 3:30 p.m. Central European time (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: RESULTS OF A PHASE III, DOUBLE-BLIND, RANDOMIZED, 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 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). Both Zenvia treatment groups had lower pain ratings than placebo patients (p less than or equal to 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 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.
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 of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways, through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of Involuntary Emotional Expression Disorder (IEED) 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.
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 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 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.
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.
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Posted: May 2007