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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

e using the total PEC score.  In each study, change from baseline for each of the five items comprising the total PEC score (hostility, uncooperativeness, excitement, poor impulse control and tension, each scored 1-7) was determined starting at 10 minutes post-dose.  In addition, patients were grouped by baseline severity of agitation (median split) using the total PEC scores for each study and response rates for the higher and lower agitation populations were compared.

Each of the five items comprising the PEC scale improved with AZ-004 treatment, with differences from placebo starting at 10 minutes after dosing.  On average, each item improved 1 to 2 units from baseline over the first two hours post-dose for both patient groups.  Thus, the change in total PEC score observed with Staccato loxapine treatment derives from similar changes on each of the five items assessed.  The median PEC score at baseline was 17 across the two studies.  For the 10 mg dose groups and patients having a total PEC score of 17 or less at baseline, there was on average a total PEC score improvement of 8.3 and 8.5 units for patients with schizophrenia and bipolar disorder, respectively.  For patients having a total PEC score of higher than 17 at baseline, there was on average a total PEC score improvement of 8.9 and 9.7 units for patients with schizophrenia and bipolar disorder, respectively.  

About the AZ-004 Cardiovascular Safety Studies

The cardiovascular safety of Staccato loxapine was assessed in a Phase 1 study of 32 subjects taking chronic antipsychotic medication and in a thorough QT study (TQT) in 48 healthy volunteers.  These results were presented in the poster presentation, "The Cardiovascular Safety of Inhaled Loxapine (AZ-004)" (Poster Session 6).

The Phase 1 study was a double-blind
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SOURCE Alexza Pharmaceuticals, Inc.; Biovail Corporation
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