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Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
Date:3/3/2008

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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 (Staccato prochlorperazine) 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. The Staccato system technology is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. 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 an
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SOURCE Alexza Pharmaceuticals, Inc.
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