The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the
treatment of acute agitation in schizophrenic patients. The study will be conducted in 120
agitated schizophrenic patients - either newly admitted to a hospital setting or a research
unit for acute agitation or already in hospital for chronic underlying conditions. Patients
meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to
Staccato Placebo. Following administration of study drug, assessment of agitation state will
be conducted at serial time points using standard agitation scales over a 24 hour period.