of the Staccato Electric Multiple Dose device, and the Company has the
exclusive right to manufacture the product for clinical development
and commercial supply.
-- AZ-007 (Staccato zaleplon). Alexza is developing AZ-007 for the
treatment of insomnia in patients who have difficulty falling asleep,
including patients who awake in the middle of the night and have
difficulty falling back asleep. In March 2008, Alexza completed
enrollment in a Phase 1 clinical trial of 40 healthy volunteers at a
single U.S. clinical center. The purpose of this trial was to assess
the safety, tolerability and pharmacokinetic parameters of a single
dose of AZ-007. Using a double-blind, randomized, dose-escalation
trial design, 4 doses of AZ-007 (ranging from 0.5 to 4.0 mg) were
compared to placebo.
In April 2008, Alexza announced positive initial results from the Phase 1 study. AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the 4 doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation self-assessed on a 100 mm visual-analog scale, showed onset of effect as early as 2 minutes after dosing with AZ-007. 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.
Conference Call Information
Alexza will host a conference call today at 4:30 p.m. Eastern Time. A
replay of the call will be available for two weeks following the event. The
conference call, replay and webcast are open to al
|SOURCE Alexza Pharmaceuticals, Inc.|
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