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Alexza Completes Target Enrollment in AZ-104 Phase 2a Clinical Trial in Migraine Patients
Date:12/18/2007

ment Board. "We believe we are on track to provide initial results from this clinical trial during the first quarter of 2008."

About Acute Migraine Headaches

According to the National Headache Foundation, approximately 13 million people in the United States have been diagnosed with migraine headaches. Acute migraine headaches occur often, usually one to four times a month. Of the estimated 29.5 million migraine sufferers (including diagnosed and undiagnosed sufferers), there are at least two groups of potential patients for whom we believe AZ-001 and AZ-104 could be effective and safe in comparison to triptans. Many migraine sufferers who do take triptans have an insufficient therapeutic response to these medications. In addition, according to the warning labels on triptans, patients with hypertension or high cholesterol, or who smoke cigarettes, are contraindicated for and should not take these medications due to potential cardiovascular health risks.

About AZ-104 (Staccato loxapine)

AZ-104 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 1 dose-escalation clinical trial, doses of Staccato loxapine ranging from 0.625 to 10 mg were generally well tolerated and there were no serious adverse events. Across all doses, pharmacokinetic analyses revealed that peak plasma levels were generally reached within the first few minutes after dosing and the drug exhibited good dose proportionality. Alexza and Symphony Allegro are also developing Staccato loxapine (AZ-004) for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. In March 2007, Alexza announced positive initial results from a Phase 2a clinical trial where a 10 mg dose of AZ-004 was statistically significantly effective, compared to placebo, in reducing agitation in schizophrenic patients following self-administration of the drug during an in-clinic study
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SOURCE Alexza Pharmaceuticals, Inc.
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