FDA issues Complete Response Letter to Alexza’s ADASUVE NDA

May 4 2012

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ADASUVE™ (loxapine) inhalation powder, 5 mg and 10 mg.  The CRL was 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.  ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

In the CRL, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.  Satisfactory resolution of these deficiencies is required before this application may be approved."  Alexza believes the deficiencies are medical device specific and readily addressable.  Alexza plans to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical.  Alexza looks forward to working to resolve the remaining issues in a timely manner.

There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL.  With respect to the ADASUVE Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the action letter has been submitted.  The CRL also contained comments on Alexza's draft product labeling.  Alexza believes that there is substantial agreement between Alexza and the FDA on the REMS and product labeling.

SOURCE Alexza Pharmaceuticals, Inc.