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 atotal value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-ECscale, 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, DevelopmentalRetardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (asper Investigator's judgment).
• 2. Patients judged to be at serious risk for suicide as per the Investigator'sjudgement.
• 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 testat screening or breastfeeding.
• 5. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with activeairways disease (such as patients with asthma or chronic obstructive pulmonarydisease).
• 6. Patients who are considered by the Investigator, for any reason, to be unsuitablecandidates for receiving inhaled loxapine, or are likely to be unable to use theinhalation device.