Alexza Announces Partnership With Endo for AZ-003 (Staccato(R) fentanyl) in Nor...(. Development of additionaldosage streng...)

Date:12/27/2007

. Development of additional dosage strengths and quantities is anticipated. The controller consists of software and hardware designed to allow safe, patient-controlled delivery of the drug. Since the Staccato system can be designed to incorporate a variety of lockout and dosing features, Alexza believes that AZ-003 may reduce the potential for abuse and diversion, and facilitate patient dose titration to the minimum effective drug dose in a simple, convenient and easy to use delivery system.

In October 2007, results from the AZ-003 Phase 1 clinical trial were presented at the 2007 American Society of Anesthesiologists Annual Meeting, in San Francisco, California. The clinical trial was conducted in 50 opioid naive healthy volunteers in two stages. In Stage 1, the arterial pharmacokinetics (PK) of 25 mcg of AZ-003 was compared to a 25 mcg dose of fentanyl administered intravenously (IV). The AZ-003 PK was equivalent to the IV fentanyl PK, with similar peak plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the curve concentration (AUC). These data suggest complete bioavailability of the inhaled dose. Mean peak arterial plasma concentrations were observed within 30 seconds for both administration routes. In Stage 2 of the clinical trial, ascending doses of AZ-003, controlled by the Staccato system, exhibited dose-proportionality of fentanyl throughout the dosing range from 50 mcg to 300 mcg, following an AUC analysis. There were no serious adverse events attributable to AZ-003 and the results from the clinical study showed that AZ-003 was generally safe and well tolerated at all doses.

About Alexza

Alexza Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid sys
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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