Loxapine is a well-established, first-generation
antipsychotic agent.
Loxapine inhalation
powder (Adasuve(®)) was recently approved in the USA and the EU for use in the acute treatment of agitation in patients with
bipolar disorder or
schizophrenia. Inhaled
loxapine is delivered by a hand-held, single-dose, single-use device that uses the Staccato(®) drug delivery system. With Adasuve(®), maximum plasma
loxapine concentrations are reached in a median of 2 min. In two randomized, double-blind, placebo-controlled, multicentre trials, inhaled
loxapine 5 or 10 mg significantly reduced agitation (assessed using Positive and Negative Syndrome Scale-Excited Component scores) in patients with bipolar I disorder or
schizophrenia, with the onset of effect seen within 10 min of administration. Inhaled
loxapine was generally well tolerated in phase III trials (which excluded patients with clinically significant acute or chronic
pulmonary disease), with the most commonly occurring adverse events including
dysgeusia and sedation. Inhaled
loxapine is contraindicated in patients with airways disease associated with
bronchospasm or acute respiratory signs or symptoms. In conclusion, inhaled
loxapine provides a novel new option for use in the acute treatment of agitation in patients with
bipolar disorder or
schizophrenia, combining a rapid onset of effect with a noninvasive route of administration.