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Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)

Wednesday, April 30, 2008 General News
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MOUNTAIN VIEW, Calif., April 29 AlexzaPharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from aPhase 1 clinical trial of AZ-007 (Staccato(R) zaleplon). AZ-007 is aninhalation product candidate being developed for the treatment of insomniapatients who have difficulty falling asleep, including patients who awake inthe middle of the night and have difficulty falling back asleep.
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"This is the fifth product candidate using our single-dose Staccatotechnology platform that has completed a Phase 1 clinical trial," said JamesV. Cassella, PhD, Senior Vice President of R&D at Alexza. "We have againshown that the Staccato system can deliver IV-like pharmacokinetics, even withwater insoluble compounds, in a simple, easy-to-use, one-breath device. Wewere pleased with the initial results. As we continue our analysis of thedata collected in this study, we plan to present these data in scientific andmedical forums at future dates, and determine the next steps for this productcandidate."
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Phase 1 Clinical Trial Results

The AZ-007 Phase 1 clinical trial enrolled 40 healthy volunteers at asingle U.S. clinical center. The purpose of this trial was to assess thesafety, tolerability and pharmacokinetic parameters of a single dose ofAZ-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.

AZ-007 delivered an IV-like pharmacokinetic profile with a median time topeak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was doseproportional across the 4 doses studied, as calculated by power analysis.Pharmacodynamics, measured as sedation assessed on a 100 mm visual-analogscale, showed onset of effect as early as 2 minutes after dosing with AZ-007.

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

About Insomnia

Insomnia is a prevalent disorder that drives a multi-billion dollar marketof prescription medications each year. An estimated 10 to 30% of the U.S.population experiences either chronic or occasional insomnia. In 2005, onesurvey conducted by the National Sleep Foundation showed that 54% of therespondents experienced a minimum of one symptom of insomnia at least a fewnights a week. Of those, respondents complained primarily of waking upfeeling unrefreshed (38%), waking up frequently during the night (32%), havingdifficulty falling asleep (21%), and waking up too early and not being able toget back to sleep (21%). There is a potentially significant clinical need forrapid and predictable onset of sleep in patients with insomnia, as well as apredictable duration of sleep and rapid, clear awakening.

About AZ-007 (Staccato zaleplon)

AZ-007 is the combination of Alexza's proprietary Staccato system withzaleplon, a drug belonging to the class of compounds known generally ashypnotics. The Staccato system technology is a hand-held, chemically-heated,single dose inhaler designed to generate and deliver excipient-free drugaerosol 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 bythe Staccato system technology, the overall product profile may match wellwith an unmet clinical need for patients with insomnia.

About Alexza Pharmaceuticals

Alexza Pharmaceuticals is an emerging specialty pharmaceutical companyfocused on the development and commercialization of novel, proprietaryproducts for the treatment of acute and intermitt
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