Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R)...(howed onset of effect as early as 2 minu...),Health

There were no serious adverse events. The most frequently reported adverse events in subjects receiving AZ-007 were dizziness and somnolence. These data indicate a rapid onset of effect, apparently directly related to the IV-like pharmacokinetics, and showed that AZ-007 was generally safe and well tolerated in this population of healthy volunteers.

About Insomnia

Insomnia is a prevalent disorder that drives a multi-billion dollar market of prescription medications each year. An estimated 10 to 30% of the U.S. population experiences either chronic or occasional insomnia. In 2005, one survey conducted by the National Sleep Foundation 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, as well as 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 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 may provide rapid sleep onset. Moreover, by coupling the shorter half-life of zaleplon with the lower dose enabled by the Staccato system technology, the overall product profile may match well with an unmet clinical need for patients with insomnia.

About Alexza Pharma
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