AVANIR RECEIVES APPROVABLE LETTER FOR NEW FAZACLO FORMULATION

Avanir Pharmaceuticals has received an approvable letter from the FDA for a new formulation of its currently marketed antipsychotic drug FazaClo (clozapine). The new formulation, if approved, will include updated packaging as well as a new 12.5-mg dosage strength. The FDA found the proposed new labeling acceptable.

In the approvable letter, the FDA identified two types of chemistry, manufacturing and controls 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 within a few 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, according to the company. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder.

"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 12.5-mg dosing strength will enhance the ability of physicians to easily titrate and fine tune the dosing of FazaClo for their patients," Randall Kaye, vice president of clinical and medical affairs for Avanir, said.