Avanir Pharmaceuticals has received marketing approval from the US Food and Drug Administration (FDA) for a new formulation of the currently marketed antipsychotic drug FazaClo (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, an Avanir press release stated.
"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.
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 behaviour 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 flavour 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 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.