MOUNTAIN VIEW, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
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. In February 2010, Alexza established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation , to develop and commercialize AZ-004 in the U.S. and Canada.
AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at www.alexza.com.
CONTACT: Thomas B. King, President & CEO, +1-650-944-7634,
tking@alexza.com, or August J. Moretti, Senior Vice President and CFO,
+1-650-944-7788, amoretti@alexza.com, both of Alexza Pharmaceuticals, Inc.
Web site: http://www.alexza.com/
