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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

, placebo-controlled, parallel group investigation of the safety of repeat doses of AZ-004 (at time 0, 4 and 8 hours) in patients 18 to 65 years of age who were taking chronic antipsychotic medication.  Participants were randomly assigned to receive either 5 mg x 3 doses, 10 mg x 3 doses, 10 mg followed by two doses of 5 mg, or placebo x 3 doses.  

There were no clinically significant mean changes in heart rate or blood pressure (BP) with repeat dosing in subjects on chronic antipsychotic medication.  In the highest dose group (10 mg x 3 doses), mean changes from baseline in systolic BP were -1.75, -3.13, and -4.38 mm Hg at 10 minutes after the first, second and third doses, respectively.

The TQT study was a double-blind, double-dummy, active- and placebo-controlled, 3 period crossover study investigating the effect on the QT interval of single doses of 10 mg AZ-004, 400 mg oral moxifloxacin (active control) and placebo.  In the TQT study, AZ-004 did not increase QT intervals, as demonstrated by the upper bound of the one-sided 95% confidence intervals placed on the point estimate of the placebo-subtracted change of QTcI being less than 10 ms at all eleven post-dose time points.  Moxifloxacin significantly prolonged QTcI by the same metrics, demonstrating assay sensitivity.  There were no clinically significant mean changes in heart rate or BP following dosing with AZ-004.

About AZ-004

AZ-004 is an anti-agitation therapeutic that combines the proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics.  Loxapine is currently available in oral formulations in the U.S. for the management of the manifestations of schizophrenia.  The Staccato system is a hand-held, chemically-heated, single-dose inhaler that delivers a drug
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SOURCE Alexza Pharmaceuticals, Inc.; Biovail Corporation
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