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Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
Date:3/3/2008

duration of efficacy is the sustained pain-free response, in which a patient reports a pain-free score at the 2-hour post-dose time point and remains pain-free for the remainder of the study period (up to 24 hours). The 2.5 mg dose of AZ-104 showed a statistically significant difference in sustained pain-free response (26%, p = 0.04) compared to placebo (8%). Sustained pain-free outcomes for the 5 mg (16%) and the 1.25 mg (21%) dose groups were not statistically significant.

Important symptoms to be managed in migraine patients are nausea, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). This proof-of-concept trial was not powered to detect differences in these measurements. AZ-104 did exhibit statistically significant improvement in nausea across all dose levels (survival analysis, p = 0.02). Positive trends were observed in the improvement of the other symptoms, but the changes were not statistically significant.

Safety Evaluations

Side effects were recorded throughout the clinical trial study period. There were no serious adverse events reported during the trial. The most common drug-related side effects (incidence . 5% in at least one drug dose
group) reported across the three drug dose groups and placebo are listed in the table below.

Placebo 1.25 mg 2.5 mg 5 mg

Side Effects (%) (%) (%) (%)

Dysgeusia 13 19 23 37

Somnolence 13 5 23 23

Fatigue 8 0 7 14

Oral discomfort 3 0 2 7

Dizziness 5 2 7 2

Hypoaesthesia,

pharyngeal 0 0 0 7

Throat irritation
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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