Alexza Pharmaceuticals provides regulatory update for AZ-004 (Staccato loxapine).

Alexza Pharmaceuticals Inc (Alexza) has scheduled an End-of Review meeting with the US Food and Drug Administration (FDA) in Dec 2010 to discuss the Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) for AZ-004 (Staccato loxapine). Alexza has submitted an Information Package to the FDA in preparation for the meeting, with the responses or proposals to the issues raised in the CRL. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients. The company anticipates the FDA meeting will be a comprehensive review of the issues identified by the FDA in the CRL, and Alexza's planned responses to those issues. The …