SAN DIEGO--(BUSINESS WIRE)--AVANIR Pharmaceuticals (NASDAQ:AVNR - News) announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zenvia(TM) (formerly referred to as Neurodex(TM)) for the treatment of involuntary emotional expression disorder ("IEED"). The Company submitted a new drug application ("NDA") in January 2006, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that AVANIR's application is approvable, subject to the FDA and AVANIR reaching agreement on what additional safety and efficacy data will be required. In accordance with FDA procedures, the Company anticipates scheduling a meeting with the agency to discuss the approvable letter. Until the Company is able to meet with the agency, it can not comment on the specifics of the approvable requirements. Additionally, the Company cannot be certain that once it has met with the FDA, that it will choose to continue with the development of Zenvia as previously planned.
"We will be working closely with the agency to determine the next steps required for the drug to receive marketing approval," said Eric K. Brandt, President and Chief Executive Officer of AVANIR. "We believe Zenvia can significantly improve the lives of patients, their families and their caregivers by reducing the emotional and social toll taken by IEED."
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®, the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. Zenvia(TM), AVANIR's lead product candidate, is under development for the treatment of involuntary emotional expression disorder. Additionally, AVANIR has initiated a Phase III clinical trial with Zenvia as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease and AstraZeneca for the treatment of cardiovascular disease. The Company's first commercialized product, abreva®, 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," "anticipate," "believe," "plan," or "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 continue the clinical development of Zenvia after meeting with the FDA or that Zenvia will receive final FDA regulatory approval. If such regulatory approval is received, there can be no assurance that AVANIR will be able to market Zenvia successfully. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are often unpredictable and outside the influence and/or 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 or obligation to update these forward-looking statements.
Patrick O'Brien, 949-389-6789
Patrice Saxon, 858-622-5202
Source: AVANIR Pharmaceuticals
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