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Staccato(R) Loxapine (AZ-004) Reduced Signs and Symptoms of Agitation as Early as Ten Minutes After Dosing in Patients with Schizophrenia or Bipolar Disorder
Date:5/26/2010

class="xn-location">Mississauga, Canada.

"As previously reported, our Phase 3 studies showed that Staccato loxapine was effective in relieving the symptoms of agitation, with an onset of effect occurring in as little as 10 minutes.  Additional analyses of our Phase 3 data show that AZ-004 rapidly treated the five individual dimensions of agitation in patients with schizophrenia or bipolar disorder," said James V. Cassella, PhD, Senior Vice President, Research and Development, Alexza Pharmaceuticals, Inc.

About the AZ-004 Efficacy Studies

The additional efficacy results from two randomized, double-blind, and placebo-controlled Phase 3 clinical trials assessing the efficacy and safety of Staccato loxapine in treating agitation in patients with schizophrenia or bipolar disorder were presented in the poster, "Treating Agitation with Inhaled Loxapine (AZ-004): Efficacy Analyses in Patients with Schizophrenia or Bipolar Disorder" (Poster Session 6).

In the Phase 3 clinical trials, loxapine was administered via inhalation using the Staccato system, which delivers thermally-generated drug aerosol to the deep lungs for rapid systemic absorption with IV-like pharmacokinetics.  Adults 18 to 65 years of age who met DSM-IV criteria for schizophrenia or bipolar I disorder, and presented with a relevant degree of agitation at baseline, were included in the trials.  A total of 344 patients with schizophrenia and 314 patients with bipolar I disorder were randomized to receive either 0 mg, 5 mg or 10 mg of AZ-004 in an in-patient treatment facility.  Up to three doses of AZ-004 could be administered to each patient during the 24-hour study period.

The primary efficacy assessment in the studies was the change from baseline at 2 hours post-dos
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SOURCE Alexza Pharmaceuticals, Inc.; Biovail Corporation
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