Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R)...(Negative Symptom Scale) Excited Componen...)

Date:2/25/2008

Negative Symptom Scale) Excited Component (also known as PEC) score, measured at 2 hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period.

A second Phase 3 clinical trial is projected to begin in Q3 2008. The design of the second study will be similar to the first trial, except that the patient population will be patients with bipolar disease.

About Acute Agitation

Acute agitation, characterized by unpleasant arousal, tension, irritability and hostility, is one of the most common and severe symptoms of many major psychiatric disorders, including schizophrenia and bipolar disorder. According to the National Institute of Mental Health (NIMH), schizophrenia afflicts about 2.4 million people in the United States and bipolar disease affects about 5.7 million American adults. We believe over 90% of these patients will experience agitation during their lifetime and that about 70% of those who experience agitation will have one to six episodes per year.

Agitated patients are often treated in an emergency room setting, and are also treated as in-patients in psychiatric hospitals or psychiatric units in standard hospitals. We believe physicians currently treat acute agitation with intramuscular (IM) injections, rapid-dissolve tablets or standard tablets. IM injections are invasive, can be disconcerting to patients as they often require the use of restraints, and can be dangerous to the medical personnel while they attempt to inject the patient. IM injections can also take up to 60 minutes to work. Oral tablets provide convenience of dosing alternatives and have a slower onset of action. Market research among physicians has identified speed of onset as an important factor that affects
'/>"/>

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

0 GOOD

Page: 1 2 3 4 5
Related biology technology :

1. The 4th Annual BIO Investor Forum to Webcast Alexzas Corporate Presentation
2. 19th Annual Piper Jaffray Health Care Conference to Webcast Alexzas Corporate Presentation
3. Alexza Elects Dr. Hal V. Barron to Its Board of Directors
4. Alexza Announces Partnership With Endo for AZ-003 (Staccato(R) fentanyl) in North America
5. Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference to Webcast Alexzas Corporate Presentation
6. Alexzas Corporate Presentation to be Webcast at the 10th Annual BIO CEO & Investor Conference
7. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
8. Dawson James Securities Initiates Research Coverage on CryoCor, Inc. (Nasdaq: CRYO) with a Strong Buy Rating and $6.00 Target Price
9. Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Bladder Cancer
10. XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
11. Nventa Initiates HspE7 Phase 1 Cervical Dysplasia Trial