AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials and submitted a New Drug Application (NDA) in December 2009. In October 2010, the Company received a CRL from the FDA, regarding its NDA for AZ-004. 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. The Company is currently evaluating the FDA's comments in the CRL and anticipates meeting with the FDA in the fourth quarter of 2010 to discuss the CRL.
For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.
Safe Harbor Statement
Alexza's policy is to only provide guidance on product candidates and corporate goals for the future one to two fiscal quarters, and to provide, update or reconfirm its guidance only by issuing a press release or filing updated guidance with the SEC in a publicly accessible document. The Company's guidance in this release is as of November 9, 2010 and financial guidance relating to the Company's current cash, cash equivalents and investments is as of September 30, 2010.
This news release contains forward-looking statements that involve significant risks and uncertainties, including our ability to establish a path for AZ-004 approval after meeting with the FDA. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be co
|SOURCE Alexza Pharmaceuticals, Inc.|
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