Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migrain...(duration of efficacy is the sustainedpai...),Health

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
'/>"/>

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

0 GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. Alexza Completes Target Enrollment in AZ-104 Phase 2a Clinical Trial in Migraine Patients
2. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
5. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
9. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
10. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
11. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)