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Alexza's AZ-004 Phase IIa Trial Meets Primary Endpoint in Treating,Schizophrenic Patients With Acute Agitation

Initial Analysis Shows Statistically Significant Changes in Agitation Levels With 10 mg AZ-004

PALO ALTO, Calif., March 26, 2007 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. today announced positive initial results from its Phase IIa clinical trial of AZ-004 (Staccato(R) loxapine) in schizophrenic patients with acute agitation. The 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, which was a statistically-significant reduction in the measure of agitation from baseline to the 2-hour post-dose time point, compared to placebo. Alexza also announced today positive top-line results from its Phase IIb clinical trial of AZ-001 (Staccato prochlorperazine) in patients with migraine headache, where AZ-001 met the primary endpoint of the Phase IIb clinical trial.

"AZ-004 is a product candidate that we believe could fill an important unmet need in the acute treatment of agitation in schizophrenic patients," said Thomas B. King, President and CEO of Alexza. "AZ-004 combines drug delivery speed comparable to that of an intravenous injection, but with the simplicity, convenience and ease of administration of a simple, one-breath inhalation."

"Antipsychotic drugs used to treat acute agitation are typically administered by intramuscular injection, usually in a clinic or in an emergency department," said James V. Cassella, PhD, Senior Vice President, Research and Development of Alexza. "The ability to provide a proven drug mechanism of action, coupled with rapid pharmacokinetics and patient self-administration, makes Staccato loxapine a potentially important new drug candidate for treating agitation in schizophrenic patients."

Clinical Trial Design

The Phase IIa clinical trial was designed as a multi-center, randomized, double-blind, placebo-controlled study of 120 patients in an in-patient clinical setting. In the trial, two doses of AZ-004 (Staccato loxapine in 5 and 10
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