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Alexza Presents Staccato® Loxapine Responder Analyses in Agitated Adult Patients with Schizophrenia or Bipolar Disease at the 2011 USPMHC Annual Conference
Date:11/8/2011

a or bipolar disorder, the number of PEC40 responders was statistically significantly greater at all time points for patients treated with either dose of Staccato loxapine, compared to patients who received Staccato placebo.  Importantly, significant differences from placebo were noted at the first assessment time of 10 minutes post-dose for both dose groups and in both patient groups.  The results for the PEC40 Responders analysis are summarized below.Staccato Loxapine PEC40 Responder AnalysisSchizophrenia Patients(% with >40% decrease from baseline PEC score)5mg

10mgTime Point

Placebo

Staccato Loxapine

Staccato Loxapine10 minutes

6.1%

17.2%

18.8%20 minutes

15.7%

29.3%

42.9%30 minutes

27.8%

46.6%

57.1%45 minutes

32.2%

50.0%

70.5%60 minutes

38.3%

57.8%

71.4%90 minutes

38.3%

61.2%

74.1%120 minutes

38.3%

62.9%

69.6%Staccato Loxapine PEC40 Responder AnalysisBipolar Disorder Patients(% with >40% decrease from baseline PEC score)5mg

10mgTime Point

Placebo

Staccato Loxapine

Staccato Loxapine10 minutes

7.6%

18.3%

21.9%20 minutes

15.2%

36.5%

49.5%30 minutes

23.8%

59.6%

61.9%45 minutes

29.5%

64.4%

70.5%60 minutes

28.6%

69.2%

72.4%90 minutes

27.6%

62.5%

72.4%120 minutes

27.6%

62.5%

73.3%CGI-I Responders Analysis

In patients with schizophrenia, 57.4% of the 5mg patients and 67.0% of the 10mg patients treated with Staccato loxapine were CGI-I responders, compared with 35.7% of placebo patients.  In patients with bipolar disorder, 66.3% of the 5mg patients and 74.3% of the 10mg patients treated with Staccato loxapine were CGI
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SOURCE Alexza Pharmaceuticals, Inc.
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