Source: DGNews  |  Posted 2 years ago

By Jenny Powers

MUNICH, Germany -- March 4, 2010 -- Acute agitation is improved in approximately 2 minutes after treatment with inhaled loxapine, according to 2 studies presented here on February 28 at the European Psychiatric Association (EPA) 18th European Congress of Psychiatry.

In addition, the mode of delivery is needle free, decreasing the risk of injury to both patient and caregivers.

James Cassella, PhD, Alexza Pharmaceuticals, Mountain View, California, and colleagues conducted 2 identically designed double-blind, randomised, placebo-controlled phase 3 studies that assessed the efficacy and safety of inhaled loxapine in reducing acute agitation in patients with schizophrenia and bipolar disorder, respectively.

The primary endpoint of both studies was the absolute change in Positive and Negative Syndrome Scale Excited Component (PEC) score from baseline to 2 hours after the first dose.

Patients had a PEC score >=14 and at least 1 PEC item of moderate severity (poor impulse control, tension, hostility, uncooperativeness, or excitement).

Both patients in the schizophrenia trial and the bipolar disorder trial received either placebo (n = 115 and 105, respectively) or a single inhalation of loxapine 5 (n = 116 and 104) or 10 mg (n = 113 and 105). Additional doses were given as required.

Loxapine at both 5 and 10 mg was significantly superior to placebo for the primary endpoint (P < .001 for each dose in each trial). Significant improvements were noted for each loxapine dose versus placebo at all time points from 10 minutes through 24 hours.

All loxapine treatment groups showed highly significant differences versus placebo at 2 hours in terms of change from baseline PEC scores and in reduced agitation.

Clinical Global Impression-Improvement -- a secondary endpoint -- and responder analysis at 2 hours post dose were also significant for each loxapine dose versus placebo in both trials.

The most frequent adverse events observed for all treatments were dysgeusia, dizziness, and sedation.

Funding for this study was provided by Alexza Pharmaceuticals.

Presentation title: Inhaled Loxapine (AZ-004, Staccato Loxapine) for Rapid and Acute Treatment of Agitation in Patients With Schizophrenia or Bipolar Disorder. Abstract P02-05