Table 3.

Published studies on inhaled FGA loxapine in the treatment of agitation in psychiatric disorders.

Authors	Year	Study Sample	Study Design	Number of Subject	Study Aims	Dose (mg/Day)	Main Findings
Allen et al.	2011	Agitated patients with schizophrenia	Phase II, randomized, double-blind, placebo-controlled study	129	To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia	Single inhalation of 5 or 10 mg of loxapine or placebo	Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders
Lesem et al.	2011	Agitated patients with schizophrenia	Phase III, randomised, double-blind, placebo-controlled, parallel-group study	344	To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia	Two or three doses of inhaled loxapine (5 or 10 mg) or placebo	Inhaled loxapine was a well-tolerated and effective treatment of agitation in schizophrenia
Kwentus et al.	2012	Agitated patients with bipolar I disorder	Phase III, randomized, double blind, placebo-controlled, parallel group inpatient study	314	To evaluate inhaled loxapine for the acute treatment of agitation in patients with bipolar I disorder	Inhaled loxapine 5 mg or 10 mg or inhaled placebo	Inhaled loxapine provided a rapid, non-injection, well-tolerated acute treatment for agitation in patients with bipolar I disorder
Krüger et al.	2015	Agitated patients with borderline personality disorder	Case series	5	To evaluate inhaled loxapine for emergency treatment of agitated patients with borderline personality disorder	Inhaled loxapine 10 mg	Inhaled loxapine was safe, well tolerated and produced rapid improvement in agitated patients with borderline personality disorder
Roncero et al.	2016	Patients with dual diagnosis	Retrospective case Series	14	Efficacy of inhaled loxapine on episodes of psychotic agitation in patients with dual diagnosis	Inhaled loxapine 10 mg	Inhaled loxapine was rapid, effective, and well accepted in all dual-diagnosis patients presenting with acute agitation in the emergency setting