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Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

e, including a blinded expert review of the flow-volume loops data from the healthy subject study as further evidence that there appears to be no consistent pattern suggestive of airway obstruction in these subjects.  Alexza also provided an analysis showing that there is no meaningful temporal relationship between placebo administration and decreases in FEV1.  Alexza believes this evidence and analysis confirms that the changes seen were likely background events in the population studied, where the repeated and extensive pulmonary function testing may have contributed to some of the observations.  Additionally, Alexza showed that the aerosol characterization does not indicate a basis for concern.  The Agency asked that Alexza reiterate these arguments in its resubmission.

In the information package, Alexza also showed that the pulmonary safety program in subjects with asthma and COPD had identified patients who may be susceptible to bronchospasm, the nature of this event, how it can be managed, and that Alexza believed the risk in these patients could be mitigated through labeling and a Risk Evaluation and Mitigation Strategy (REMS) program.  At the End-of-Review meeting, the Agency stated that it would be reasonable to propose a REMS program for the use of Staccato loxapine, and requested that as part of the Company's resubmission, Alexza provide a detailed REMS proposal including labeling, a medication guide, a communication plan, and post-approval studies to manage the potential risks.  In the resubmission Alexza must also show how to identify patients at risk of developing pulmonary side-effects, as well as a way to decide who should and should not be treated with Staccato loxapine when they present for treatment.

The FDA stated in the meeting minutes that it would likely present the AZ-004 application to an Advisory Committee.  Alexza believes that the AZ-004 NDA is a Class 2 resubmission and the r
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SOURCE Alexza Pharmaceuticals, Inc.
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