ALEXZA COMPLETES ENROLLMENT IN SCHIZOPHRENIC AGITATION TRIAL

Alexza Pharmaceuticals has completed patient enrollment in its Phase IIa clinical trial of AZ-004 (Staccato loxapine). AZ-004 is an inhalation product candidate being developed for the acute treatment of agitation in schizophrenic patients.

The Phase IIa clinical trial was a multicenter, randomized, double-blind, placebo-controlled study of 120 patients in an inpatient clinical setting. In the trial, two doses of AZ-004 (5 and 10 mg) and placebo were tested. The primary aim of the clinical trial was to assess the safety and efficacy of a single dose of AZ-004 in acutely treating agitation in schizophrenic patients. Assessments of a patient's agitation state were conducted at serial time points using both standard agitation scales and objective measures of patient's movement over a four-hour period, with follow-up assessments for the next 20 hours. The change in the Positive and Negative Syndrome Scale Excited Component was the primary efficacy measure for the clinical study. Safety evaluations were made throughout the clinical trial period.

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as antipsychotics. In a Phase I dose-escalation clinical trial in healthy subjects, AZ-004 was generally well tolerated at all doses tested and there were no serious adverse events. Alexza believes the noninvasive nature and rapid pharmacokinetic properties resulting from administration via the Staccato system make AZ-004 a viable product candidate for treating agitation episodes in schizophrenic patients.