Press Release: AVANIR Pharmaceuticals Receives FDA Approval for New Formulation of FazaClo
AVANIR Pharmaceuticals (AVNR) Receives FDA Approval for New Formulation of Currently Marketed Antipsychotic Drug FazaClo ALISO VIEJO, Calif. -- AVANIR Pharmaceuticals today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for a new formulation of the currently marketed antipsychotic drug FazaCloÂ® (clozapine, USP) Orally Disintegrating Tablets. The new formulation provides bottle packaging and a new 12.5 mg dosage strength, in addition to 25 mg and 100 mg dosage strengths. Previously FazaClo was only available in 25 mg and 100 mg dosage strengths in special blister packaging. The new formulation of FazaClo in bottles is expected to be more convenient for health care professionals and patients, and will be available in pharmacies shortly. "The new formulation and packaging should improve the utility of FazaClo and make it easier to offer to patients within my practice," said Michael J. Reinstein, M.D., Director of the Uptown Research Mental Health Center in Chicago. "Having the flexibility of the new 12.5 mg dose will also provide a wider range of dosing options to better match patients with the appropriate dose given the severity of their condition and the desired drug benefits." AVANIR received an approvable letter in January 2007 for this new formulation of FazaClo. Final approval was granted after addressing the FDA concerns raised in that letter. About FazaClo Of the estimated two-and-a-half million Americans who suffer from schizophrenia, approximately one-third are termed treatment-resistant because they derive little or no benefit from conventional antipsychotic medications. FazaClo is the only orally disintegrating form of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenia drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk for suicide. FazaClo is supplied as an innovative orally disintegrating tablet that uses proprietary formulation technologies licensed from CIMA LABS INC. FazaClo has a pleasant mint flavor and is designed to disintegrate in the mouth in about 30 seconds and is swallowed reflexively in saliva. The benefits of an orally disintegrating tablet can be important in treating a disease such as schizophrenia where patient non-compliance is a significant problem often leading to relapse and hospitalization. AVANIR maintains the FazaClo Patient Registry because of the risk of rare, but severe adverse events such as agranulocytosis and granulocytopenia associated with the use of clozapine. 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. About AVANIR AVANIR Pharmaceuticals is focused on acquiring, developing 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, 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 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(TM), is the subject of an approvable letter from the FDA. Additionally, AVANIR recently completed a Phase III clinical trial of Zenvia in patients with diabetic peripheral neuropathic (DPN) pain, where the primary endpoint was met. AVANIR has an ongoing development program with Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. The Company's first commercialized product, AbrevaÂ®, 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 "should," "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. For example, there can be no assurances that the new formulation of FazaClo will be successfully commercialized or that patients and caregivers will perceive the new formulation to be superior. 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.