Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R)...(can be disconcerting to patients as they...),Health

Date:7/24/2008

can be disconcerting to patients as they often require the use of restraints, and can be dangerous to the medical personnel while they attempt to inject the patient. IM injections can also take up to 60 minutes to work. Oral tablets provide convenience of dosing alternatives, but have a slower onset of action. This market research has also identified speed of onset as an important factor that affects the choice of therapy for treating acute agitation. Alexza believes that many patients with schizophrenia or bipolar disorder can make informed decisions regarding their treatment in an acute agitative state and would prefer a rapid-acting, noninvasive treatment.

In summary, Alexza believes there is a significant unmet medical need for an acute agitation treatment option that will provide a fast onset of effect, that is noninvasive and safer to administer, and that allows patients to be active participants in choosing acceptable treatment options.

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics. The Staccato system 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. Alexza has completed four clinical trials with AZ-004, including a 50 subject Phase 1 study in healthy volunteers, a 129 patient Phase 2 study in agitated schizophrenic patients, a 32 patient multiple-dose tolerability and PK study in non-agitated schizophrenic patients, and a 344 patient Phase 3 study in agitated schizophrenic patients. Alexza projects that the initial results from the first Phase 3 study will be reported before the end of September 2008.

The Company believes that the unique delivery of loxapine via the Staccato system will provide rapid onset of drug effect, as measured by a reduction in the sig
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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