A Study of Staccato Loxapine (ADASUVE®) for Inhalation

Inclusion Criteria: * 1\. Male and female patients between the ages of 18 to 65 years, inclusive. * 2\. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder. * 3\. Patients are judged to be clinical mild to moderate agitation at baseline with a total value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of ≥3 on CGI-S scale. * 4\. Patients are judged to be cooperative by the Investigator. * 5\. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained. Exclusion Criteria: * 1\. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment). * 2\. Patients judged to be at serious risk for suicide as per the Investigator's judgement. * 3\. Patients with a history of allergy or intolerance to loxapine or amoxapine. * 4\. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding. * 5\. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease). * 6\. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be …