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

MOUNTAIN VIEW, Calif., Jan. 18, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting.  In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

"We appreciate the FDA's review of the first NDA for our novel Staccato technology and we are working to address issues raised in the Complete Response Letter," said Thomas B. King, Alexza President and CEO.  "Based on the guidance received in our End-of-Review meeting, we believe all of the issues raised in the CRL are resolvable.  We plan to resubmit the AZ-004 NDA in July 2011."

As reported in October 2010, the FDA stated in the CRL that their primary clinical safety concern was related to data from the three Phase 1 pulmonary safety studies with AZ-004.  This concern was primarily based on observed, dose-related post-dose decreases in forced expiratory volume in one second, or FEV1, a standard measure of lung function, in healthy subjects and in subjects with COPD and asthma.  The Agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004.  

In the information package submitted to the FDA in response to the CRL and in preparation for the End-of-Review meeting, Alexza presented evidence that the placebo device is saf
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SOURCE Alexza Pharmaceuticals, Inc.
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