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Alexza Reports 2008 Year-End Financial Results and Updates Clinical Pipeline Status
Date:3/10/2009

measured at 2 hours after the first dose. Both the 5 mg and 10 mg doses of AZ-004 met these primary and secondary endpoints. All results were considered statistically significant at the p < 0.05 level, as compared to placebo, and all statistical analyses were made on an intent-to-treat basis. The 10 mg dose of AZ-004 exhibited a rapid onset of effect, with statistically significant reduction in agitation at 10 minutes post-dose, the first time point measure in the study. The reduction of agitation was generally sustained through the 24-hour study period. Various additional assessments of a patient's agitation state were conducted at serial time points using the PEC score over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects were recorded for each patient throughout the clinical trial period. The administration of AZ-004 was generally safe and well tolerated. The most common side effect, and the only side effect reported by at least 10% of the patients in any treatment group, was taste. This side effect was rated as mild in all patients.

In September 2008, the Company announced positive results from its first Phase 3 clinical trial of AZ-004 in 344 acutely agitated schizophrenic patients. The study design was similar to the clinical trial outlined above. Both the 5 mg and the 10 mg doses of AZ-004 met the primary and secondary endpoints of the study. The administration of AZ-004 was generally safe and well tolerated in this patient population.

AZ-004 has been licensed to Symphony Allegro, Inc., or Symphony Allegro, and the Company has the right to repurchase all rights to this product candidate.

  • AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose version of AZ-004. In January 2009, Alexza initiated an AZ-104 outpati
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine news :

1. Alexzas Corporate Presentation to be Webcast at the Cowen & Company 29th Annual Health Care Conference
2. Alexza to Announce 2008 Financial Results and Update Its Clinical Pipeline on Tuesday, March 10, 2009
3. Alexza Pharmaceuticals Promotes Peter D. Noymer, PhD to Vice President, Product R&D
4. Alexza Pharmaceuticals Announces Upcoming Conference Participation and Webcasts
5. Alexza Reports 2008 Third Quarter Financial Results and Updates Development of Product Candidates
6. Alexza to Announce 2008 Third Quarter Financial Results and Update Its Clinical Pipeline on Thursday, November 6, 2008
7. Anthony Clarke, PhD Joins Alexza Pharmaceuticals as Vice President, International Development Operations
8. Jeffrey S. Williams Rejoins Alexza Pharmaceuticals as President, Alexza Singapore Pte. Ltd.
9. Carlos A. Parra Joins Alexza Pharmaceuticals as Vice President, Quality
10. Alexzas Corporate Presentation to be Webcast at the Seventh Annual JMP Securities Research Conference and the 2008 Citi Investment Research Global Healthcare Conference
11. Alexza to Webcast Investor and Analyst Day Presentations
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