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Alexza Pharmaceuticals Inc. Message Board

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  • mattoruu mattoruu Aug 17, 2010 2:37 AM Flag

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    I thought the opposite, that Moretti WAS confident that Alexza could use the technology to keep the patient from overdosing (for AZ-007). That was one of the advantages he said for doing Staccato Zaleplon. The Staccato device itself will keep patients from overdosing. The device they would use for Staccato Zaleplon will have an electronic lockout feature and a patient ID feature. The lockout feature will keep patients from using the device more than once during a set period of time and the ID will ensure that only the patient will be able to use the device.

    --------------------

    As for the medically surprised restriction for AZ-004, that's only because all clinical work was done in a medical supervised environment. It doesn't mean AZ-004 can't be used away from the hospital safely. It just meant Alexza doesn't have any info/data one way or the other to give to the FDA yet.

    Alexza would need to do an additional followup safety study later for an outpatient setting to get rid of that restriction (which they've already have planned for). And it is possible that the FDA will approve the drug without any setting restriction at all (possible, although the restriction is the most likely outcome initially).

    One of the future milestones payments from the Biovail deal is AZ-004 approval in an outpatient setting. So Alexza already has plans for this.

    (Please excuse any grammar/spelling mistakes. It is late and too tired to edit myself. haha)

 
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