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Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
Date:7/12/2010

ore times per week.  Of those who experienced these awakenings, 43% reported difficulty in resuming sleep after waking and over 90% reported the condition persisting for more than six months.

A 2008 "Sleep in America" poll conducted by the National Sleep Foundation found that 42% of respondents awakened during the night at least a few nights a week, and 29% said they woke up too early and could not get back to sleep. Other clinical studies have reported between 25% and 35% of people experience nocturnal awakenings at least three nights a week.

In a Phase 1 clinical trial, AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak plasma concentration for the drug of 1.6 minutes.  Pharmacodynamics, measured as sedation assessed on a 100 mm visual analog scale, showed onset of effect as early as 2 minutes after dosing with AZ-007.  AZ-007 was dose-proportional across the four dosage strengths studied in this clinical trial, and was generally safe and well tolerated in this volunteer population.

"Our Phase 1 clinical trial produced highly encouraging results," Cassella continued.  "Our Phase 2 program will be designed to demonstrate similar findings in patients in the sleep lab, focusing on onset, duration and offset of sleep following dosing with AZ-007."

About Staccato Nicotine and Addicere Therapeutics

Alexza's original concept of using heat to create aerosols, as envisioned by founder Dr. Alejandro Zaffaroni, was stimulated, in part, by studying early work on the "smokeless cigarette".  Nicotine, as a pure substance, is not technically feasible with the Staccato system technology.  However, in 2008, Alexza scientists were able to create simple nicotine salts that yielded nicotine aerosols of h
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SOURCE Alexza Pharmaceuticals, Inc.
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