Staccato Loxapine in Agitation (Proof of Concept)

Exclusion criteria

• . Patients with agitation caused by acute intoxication must be excluded. Positive identification of non-prescription drugs during urine screening excludes the subject.
• . Patients treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics within 4 hours prior to study drug administration must be excluded.
• . Patients treated with injectable depot neuroleptics within one dose interval prior to study drug administration must be excluded.
• . Patients with a history of allergic reactions to loxapine or amoxapine must be excluded.
• . Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
• . Patients who have Parkinson's disease, hydrocephalus, seizure disorder, or history of significant head trauma must be excluded.
• . Patients with laboratory or ECG abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the patient's participation in the study must be excluded.
• . Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease must be excluded.