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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

significant improvements in pain response were observed in 76.7% of patients at the 5 mg dose (p = 0.02), 79.1% of patients at the 2.5 mg dose (p = 0.01) and 67.4% of patients at the 1.25 mg dose (p = 0.18), compared to 51.3% of patients receiving placebo. Using survival analysis for pain relief response, all three dose groups were statistically superior (p < 0.05) to placebo during the 4-hour post-treatment time period that the patients remained in the clinic.

Primary Efficacy Endpoint -- Pain Relief at 2-Hours Post-Dose

Number of Patients Achieving % p-value

Treatment Patients Pain Relief Pain-Relief vs Placebo

Placebo 39 20 51.3% na

1.25 mg 43 29 67.4% 0.18

2.5 mg 43 34 79.1% 0.01*

5 mg 43 33 76.7% 0.02*

* Statistically significant (p < 0.05)

Additional Efficacy Endpoints

Additional measures of efficacy included the achievement of a pain-free response, in which a patient has a post-dose pain score of 0 (or "no") headache pain. In the trial, AZ-104 showed statistically significant differences from placebo in this measure at the 2-hour time point with 30% of patients achieving pain-free status at the 2.5 mg dose (p = 0.01) and 28% at the 1.25 mg dose (p = 0.02). While the 5.0 mg dose was numerically superior to placebo with 21% pain-free, this group did not achieve a statistically significant response, compared to placebo (p = 0.12). The rate of pain-free response at 2 hours in patients receiving placebo was 8%. Using survival analysis for pain free response, all three dose groups were statistically superior (p < 0.05) to placebo during the 4-hour post-treatment time period that the patients remained in the clinic.

A commonly used measure of
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SOURCE Alexza Pharmaceuticals, Inc.
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