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Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
Date:2/5/2008

, single-administration, placebo-controlled study in

approximately 160 migraine patients with or without aura. Three doses

of AZ-104 (1.25, 2.5 and 5 mg) were evaluated against placebo in the

clinical trial. Using the IHS (International Headache Society) 4-point

rating scale, the primary efficacy endpoint is pain-relief response at

2 hours post-administration. Alexza expects preliminary findings to be

released by the end of Q1 2008. AZ-104 is being developed through

Symphony Allegro.

-- AZ-002 (Staccato alprazolam) is being developed for the acute treatment

of panic attacks associated with panic disorder. Alexza is conducting

a Phase 2a proof-of-concept clinical trial in panic disorder patients.

The primary aim of the in-clinic clinical trial is to assess the safety

and efficacy of a single dose of AZ-002 in treating a

pharmacologically-induced panic attack. Alexza has completed the

open-label, lead-in segment of the clinical trial, identifying the 1 mg

AZ-002 dose as an acceptable dose in terms of its safety and efficacy

profile, and has initiated the randomized, double blind,

placebo-controlled segment of the clinical trial. Alexza expects the

enrollment of this clinical trial to be completed by the end of Q2

2008. AZ-002 is being developed through Symphony Allegro.

-- AZ-003 (Staccato fentanyl) is being developed for the treatment of

breakthrough pain in cancer and non-cancer patients. In December 2007,

Alexza entered into a license and development agreement with Endo

Pharmaceuticals Holdings Inc. for development of AZ-003 and the

fentanyl class of molecules in North America. In the partnership,

Alexza has primary responsibility for the development of the Staccato

Electric Multiple Dose device and the exclusive right to manufactu
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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