Navigation Links
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

of the Symphony Allegro Development Board. "These promising initial results are exciting. We look forward to working with our colleagues at Symphony Allegro to further analyze the data and determine the next steps in the clinical development of AZ-104."

AZ-104 Phase 2a Clinical Trial Design

The Phase 2a clinical trial was an in-clinic, multi-center, randomized, double blind, placebo-controlled study. The study was designed to evaluate the treatment of a single migraine attack in each of 160 migraine patients, with or without aura. In the trial design, three doses of AZ-104 (Staccato loxapine in 1.25, 2.5 and 5 mg doses) were evaluated against placebo (a Staccato device containing no drug). Patients reported to the clinic when they felt the onset of a migraine and were treated once their headache was considered to be of moderate or severe intensity. Patients stayed in the clinic for 4 hours post-dosing for various assessments and were monitored via patient diary for the remainder of the 24-hour evaluation period. The clinical trial enrolled 168 patients: 43 patients in the 1.25 mg dose group, 43 patients in the 2.5 mg dose group, 43 patients in the 5 mg dose group and 39 patients in the placebo dose group.

Patients rated their headache pain using the International Headache Society (IHS) 4-point rating scale. The primary efficacy endpoint was headache pain relief (headache pain rated as mild or none) at 2-hours post-dose. Secondary efficacy endpoints for the trial included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia. All results were considered statistically significant at the p < 0.05 level and all analyses were made on an intent-to-treat basis. Side effects were recorded throughout the clinical trial study period.

Primary Efficacy Endpoint

AZ-104 met the primary efficacy endpoint of the clinical trial for two doses of the drug compared to placebo. Statistically
'/>"/>

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

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)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Tianyin Pharmaceutical Co., Inc. (NYSE MKT: ... biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics ... the Company achieved the Public Notice (Gong Shi) ... of TPI,s Qionglai Facility (QLF) from the China ... period is a significant procedure of GMP certification ...
(Date:12/22/2014)... JUNCTION, N.J. , Dec. 22, 2014 /PRNewswire/ ... company marketing its CytoSorb® blood purification technology to ... surgery patients in 28 countries worldwide, today announced ... Russo , MD, FACS, as its Senior Vice ... Dr. Di Russo ...
(Date:12/22/2014)... --  TRU-D SmartUVC LLC, producers of the first ... that the General Services Administration has awarded the company ... This newly formed agreement will allow TRU-D SmartUVC ... including Department of Veteran Affairs and Department of Defense ... solutions for the Ebola effort in West ...
Breaking Medicine Technology:TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 5TRU-D SmartUVC LLC Awarded General Services Administration Contract to Expand Government Customer Base 2
(Date:12/25/2014)... Recently, BellasDress has launched its ... dresses. BellasDress has chosen their best-selling lace wedding dresses, ... the holiday season. , Now, BellasDress.com features popular ... here at discount prices. The business hopes everyone can ... , “All our elegant products are made ...
(Date:12/25/2014)... Recently, LunaDress.co.uk has updated its blog to provide ... Now, all of the models at LunaDress.co.uk come with big discounts, ... the wedding veil can turn out to be a most exciting ... veil can always bring surprise to a wedding. On the updated ... choose veils for a big day . , Going out ...
(Date:12/25/2014)... (HealthDay News) -- Among early stage breast cancer patients ... of one percent will eventually develop leukemia as a ... The finding comes from a review of more than ... and it suggests that the risk for developing treatment-related ... previously thought. "The frequency of bone marrow cancers ...
(Date:12/25/2014)... “ SmileStix ” was featured on NewsWatch as part ... mobile applications on the iOS, Android, and Windows markets. Andrew ... the app review and shared with viewers how this is ... old saying goes, “A picture says a thousand words.” It’s ... a single image, because each picture holds a unique and ...
(Date:12/25/2014)... Phoenix, AZ (PRWEB) December 25, 2014 ... comes to outstanding customer service and affordable quality regarding ... metropolitan area announces recognition in 2014 by the “Queen ... and Sons has earned an impressive reputation over the ... pricing on a wide range of contractor services for ...
Breaking Medicine News(10 mins):Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 3Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 3
... , LOS ANGELES, Sept. 14 The Cooperative ... CAP Cares, a program created to help its physician members preserve ... , , CAP is encouraging its physician members ... that is either a known risk of medical care (a complication) ...
... stomach-acid reducer used to prevent stress ulcers in critically ... of those patients contracting pneumonia threefold, according to researchers ... pneumonia is the leading cause of infection-related deaths in ... average of seven to nine days, cost of care, ...
... SAN FRANCISCO, Sept. 14 Blue Shield of California ... Blue Shield of California,s Individual, Small Group, and Government Business Unit ... and overall results for the ISGBU Senior lines of business. He ... seniors. Russo will be based in Woodland Hills, Calif. , ...
... , , , LOS ... job and in the kitchen. Now you can serve up some of ... purchasing the new Terry Farrell Firefighters Fund California Firehouse Cookbook, you,ll get ... their families. , , Created by the Fund and ...
... , DETROIT, Sept. 14 Blue Care Network ... rewards individuals for committing to healthy lifestyles, reached the 100,000 member ... "By reaching this major milestone, it is evident our group customers ... healthier workforce," said Jeanne Carlson, BCN president and chief executive officer. ...
... Improving health key to health care reform success; healthy employees ... SAN FRANCISCO, Sept. 14 Today the non-profit ... of more than 400 employers indicating that less than five percent ... in the face of recent reports that employers are likely to ...
Cached Medicine News:Health News:Cooperative of American Physicians, Inc. Launches CAP Cares 2Health News:Popular stomach acid reducer triples risk of developing pneumonia 2Health News:Marc Russo Named Vice President of Individual, Small Group, and Government Business Unit at Blue Shield of California 2Health News:UPDATE: Favorite California Firehouse Recipes Fill New Cookbook 2Health News:UPDATE: Favorite California Firehouse Recipes Fill New Cookbook 3Health News:UPDATE: Favorite California Firehouse Recipes Fill New Cookbook 4Health News:UPDATE: Favorite California Firehouse Recipes Fill New Cookbook 5Health News:UPDATE: Favorite California Firehouse Recipes Fill New Cookbook 6Health News:Blue Care Network's Healthy Blue Living(SM) Membership Exceeds 100,000 2Health News:Survey Finds Employers Plan to Continue or Expand Health & Productivity Programs in Spite of Tough Economy 2
... of three software components that comprise ... ,Three software components comprise the SmartPill ... software, SmartPill Data Receiver software and ... are integrated and indispensable parts of ...
... software links sampler, patient and ... making data readily available to ... of incorrect patient identification. ... 1st automatic, the worlds first ...
... One of three software components ... System., ,Three software components comprise ... pH.p Capsule software, SmartPill Data Receiver ... three components are integrated and indispensable ...
... The standard pH Testing Application ... with the Bravo™ Catheter-Free pH ... Recorder, and the Synectics Digitrapper ... The PNET software and Digitrappers ...
Medicine Products: