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Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

2-hours post-dosing.

The duration of the clinical benefit of AZ-004, as measured by the need for additional study drug and/or rescue medication by the 4-hour time point, was significantly different between drug and placebo, and appeared to be dose related. Compared to the 64% of the placebo group that required more than one dose of the study drug and/or rescue medication, 40% of the 5 mg group (p = 0.0019) and only 25% of the 10 mg group (p < 0.0001) required more than one dose of study drug and/or rescue medication. A similar statistically significant pattern was evident for the 24-hour time point.

A responder analysis was conducted using the CGI-I scale. A responder was defined as having a CGI-I score at 2 hours after the first dose of either a 1 (very much improved) or 2 (much improved). Both the 5 mg (66% responders; p < 0.0001) and 10 mg (74% responders; p < 0.0001) doses of AZ-004 were statistically superior to placebo (28% responders).

Safety Evaluations

Side effects were recorded throughout the study period. The administration of AZ-004 was generally safe and well tolerated. There were no serious adverse events. The only common side effect reported (> 10% in any treatment group) was taste (dysgeusia). This side effect was rated as mild in all patients and occurred in both drug and placebo dose groups.


                       Treatment Emergent Side Effects
                        (> 2% in any treatment group)

                              Placebo      5 mg AZ-004   10 mg AZ-004
    Term                      (n=105)         (n=104)        (n=105)
    Dysgeusia                    6%             17%            17%
    Sedation / Somnolence        3%              7%             6%
    Dizziness                    8%              6%             5%
    Throat irritation            1%              0%             4%
    Fatigue                     
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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