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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

NEW ORLEANS, May 26 /PRNewswire-FirstCall/ -- Results of clinical studies in patients with schizophrenia or bipolar disorder demonstrated that Staccato® loxapine (AZ-004) reduced agitation in patients, regardless of the level of agitation at baseline.  Improvement in agitation levels were observed as early as 10 minutes after dosing on the standard components of agitation as measured by the Positive and Negative Syndrome Scale - Excited Component (PEC).  Staccato loxapine also had no significant hemodynamic effect in subjects taking chronic antipsychotic treatment and did not significantly prolong the QT interval at therapeutic doses.  These and other efficacy and safety data from clinical trials involving more than 700 patients and subjects were presented in poster presentations today at the Annual Scientific Sessions of the American Psychiatric Association meeting in New Orleans, LA.

Staccato loxapine is being developed by Alexza Pharmaceuticals, Inc. (Mountain View, CA) for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.  Agitation is distressing for patients and their caregivers as well as a challenge for health-care professionals to manage.  An AZ-004 New Drug Application is currently under review by the U.S. Food and Drug Administration, with a PDUFA goal date of October 11, 2010.  The studies being reported were sponsored by Alexza, and the AZ-004 rights for the treatment of psychiatric and/or neurological indications and the symptoms associated with these indications have been licensed in the United States and Canada to Biovail Laboratories International, SRL, a subsidiary of Biovail Corporation of '/>"/>

SOURCE Alexza Pharmaceuticals, Inc.; Biovail Corporation
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