AVANIR Receives FDA Approvable Letter for New Formulation of Currently Marketed Antipsychotic Drug FazaClo
Aliso Viejo, Calif., January 30, 2007 -- Avanir Pharmaceuticals (NASDAQ: AVNR) announced today that it has received an approvable letter and acceptable labeling from the U.S. Food and Drug Administration (FDA) for a new formulation of its currently marketed antipsychotic drug FazaClo® (clozapine, USP). The new formulation, if approved, will include updated packaging as well as a new 12.5mg dosing strength. In the approvable letter, the FDA identified two types of chemistry, manufacturing and control (CMC) data that need to be provided: updated stability data and disintegration specifications. The Company is preparing its response to the FDA and currently anticipates resolving the issues to obtain final marketing approval in the coming months. FazaClo is the only orally disintegrating form of clozapine which is indicated 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.
"The new packaging and 12.5mg strength of FazaClo, if approved, will provide additional convenience benefits to patients, pharmacies, and institutions," said Randall E. Kaye, M.D., Vice President of Clinical and Medical Affairs of Avanir. "While maintaining the unique benefits of the orally disintegrating tablet, this new formulation and packaging will provide patients with more convenient access to FazaClo as the need for blister packaging will be eliminated. This new formulation will allow the tablets to be packaged in standard bottles that will enable pharmacies and institutional customers that administer FazaClo to store and dispense the medication in a manner consistent with other formulations of clozapine. Additionally, the 12.5mg dosing strength will enhance the ability of physicians to easily titrate and fine tune the dosing of FazaClo for their patients."
Of the two-and-a-half million Americans who suffer from schizophrenia, approximately one-third are termed treatment-refractory because they derive little or no benefit from conventional antipsychotic medications. FazaClo® (clozapine, USP), is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia and is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state FazaClo is currently supplied in an innovative orally disintegrating tablet that uses the proprietary OraSolv™ technology licensed from CIMA LABS INC. FazaClo is designed to disintegrate in the mouth in about 15 to 30 seconds with a pleasant mint flavor and is then swallowed reflexively in saliva. This advantage may be important in treating a disease such as schizophrenia where non-compliance is a significant problem leading to relapse and potential hospitalization. Because of the risk of agranulocytosis and granulocytopenia associated with the use of clozapine, Avanir maintains the FazaClo Patient Registry. Prescribing health care practitioners, dispensing pharmacists and FazaClo patients can be registered in the FazaClo Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of total white blood cell (WBC) counts and absolute neutrophil count (ANC) values and related information for patients who receive the FazaClo brand of clozapine. Please see full Prescribing Information including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, dementia-related psychosis in elderly patients, and other adverse cardiovascular and respiratory effects at www.fazaclo.com.
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™, Avanir's lead product candidate for the treatment of involuntary emotional expression disorder (IEED) also known as pseudobulbar affect, is the subject of an approvable letter from the FDA and future development plans for this product candidate are under consideration. The Company does not know at this time what impact, if any, the ongoing discussions with the FDA for IEED may have on the development of Zenvia for other indications. Additionally, Avanir has completed the patient recruitment in 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.
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 the new formulation. 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, in the Company's Current Report on Form 8-K filed with the SEC on November 3, 2006, 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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|Jan 30, 2007|