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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

al is to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double blind, randomized, dose-escalation trial design, four doses of AZ-007 (ranging from 0.5 to 4.0 mg) will be compared to placebo.

About Insomnia

Insomnia is a prevalent disorder that drives almost $5 billion in worldwide sales of prescription medications each year, with about 10 to 30% of the U.S. population experiencing either chronic or occasional insomnia. In a large survey conducted by the National Sleep Foundation in 2005, results showed that 54% of the respondents experienced a minimum of one symptom of insomnia at least a few nights a week. Of those, respondents complained primarily of waking up feeling unrefreshed (38%), waking up frequently during the night (32%), having difficulty falling asleep (21%), and waking up too early and not being able to get back to sleep (21%). There is a potentially significant clinical need for rapid and predictable onset of sleep in patients with insomnia, coupled with a predictable duration of sleep and rapid, clear awakening.

About AZ-007 (Staccato zaleplon)

AZ-007 is the combination of Alexza's proprietary Staccato system with zaleplon, a drug belonging to the class of compounds known generally as non-benzodiazepine hypnotics. 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.

The Company believes that AZ-007's unique delivery via the Staccato system may provide rapid sleep onset. Moreover, coupling the short half-life and short duration of effect of zaleplon, with a lower dose enabled by the Staccato system technology, the overall product profile may match well with an unmet clinical need for patients with insomnia.

Clinical Pipeline Development Status

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SOURCE Alexza Pharmaceuticals, Inc.
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