Navigation Links
Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

or acute agitation: speed of onset, reliability of medication delivery and patient preference. The Company believes AZ-004 is a product candidate that has the potential to be the first product, if approved, that would be able to both meet these needs for most agitation sufferers and allow physicians to effectively respond to the potential rapid escalation of an acute agitation episode.

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics. The Staccato system is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. Alexza has now completed five clinical trials with AZ-004, enrolling more than 800 patients, and has announced positive results from all of these studies.

These five studies include a 50 subject Phase 1 study in healthy volunteers, a 129 patient Phase 2 study in agitated schizophrenic patients, a 32 patient multiple-dose tolerability and pharmacokinetic study in non-agitated schizophrenic patients, a 344 patient Phase 3 study in schizophrenic patients with acute agitation, and a 314 patient Phase 3 study in bipolar disorder patients with acute agitation. Alexza completed an end- of-Phase 2 meeting with the FDA for AZ-004 in September 2007, and believes it has a clear understanding of the development requirements for filing an NDA for AZ-004.

In the previously reported Phase 3 study in agitated schizophrenic patients, both the 5 mg and 10 mg doses of AZ-004 met the primary endpoint of the trial and the key secondary endpoint of the trial, both doses showing a highly statistically significant reduction in agitation in both endpoints, as compared to placebo. The 10 mg dose of AZ-004 exhibited a rapid onset of effect, w
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
2. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
3. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
5. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
8. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
9. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
10. TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
11. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... 18, 2014 Radiology information ... is used to store, manipulate, and distribute patient ... patient tracking and scheduling system, result reporting, and ... with HIS and other databases improves the hospital ... patient scheduling, patient list management, radiology department workflow ...
(Date:12/19/2014)... REDWOOD CITY, Calif., Dec. 18, 2014 ... on the development of medical diagnostics based on ... of gas flow, today announced financial results for ... 30, 2014. "Following the completion of ... well positioned to maximize the recently initiated CoSense® ...
(Date:12/19/2014)... and LYON, France , Dec. 19, ... LLY ) and Adocia (Euronext Paris: FR0011184241 – ADOC) ... an ultra-rapid insulin, known as BioChaperone Lispro, for treatment ... BioChaperone Lispro relies on Adocia,s proprietary BioChaperone® technology and ... and Adocia will develop BioChaperone Lispro with the goal ...
Breaking Medicine Technology:The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 2The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 3Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3
... , NEW YORK, ... research report is available in its catalogue: , ... , http://www.reportlinker.com/p0164335/Cardiac-Pacemakers---A-World-Market-Analysis.html , Pacemaker devices constitute ... market. The worldwide cardiac pacemakers market is characterized by ...
... ... a new market research report is available in its ... Global Market Perspective , http://www.reportlinker.com/p0164320/Electrodes-for-Medical-Devices---A-Global-Market-Perspective.html , ... muscle and nerve cells that are created by chemical ...
Cached Medicine Technology:Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 2Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 3Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 4Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 5Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 6Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 7Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 8Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 9Reportlinker Adds Cardiac Pacemakers - A World Market Analysis 10Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 2Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 3Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 4Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 5Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 6Reportlinker Adds Electrodes for Medical Devices - A Global Market Perspective 7
(Date:12/20/2014)... The Twin Cities DI Day is ... the nation! Over 250 financial professionals come together each ... the industry, get motivated to protect their clients and ... and overcoming the challenges of disability. , On September ... came together to attend The 13th Annual Twin Cities ...
(Date:12/19/2014)... Sweetdressy.com , a leading wedding dress manufacturer ... of cheap prom dresses for ladies worldwide. The prom ... and clients can buy these dresses at the website ... cool cuts and delicate craftsmanship, and most of them ... Discount shipping costs are available for all of their ...
(Date:12/19/2014)... Santa Rosa, CA (PRWEB) December 19, 2014 ... 2x4 and 5x5 SuperClone Rooms. SuperCloset continues to offer ... grow solutions. Pair one of the new SuperClone Rooms ... truly professional, perpetual, and turnkey indoor hydroponic grow room ... cloner in the world, SuperCloset’s SuperPonic SuperCloner 50 ...
(Date:12/19/2014)... The print component of Vision and Hearing ... the Toronto Star, with a circulation of approximately 230,433 ... component is distributed nationally through a vast social media ... and partner outlets. To explore the digital version of ... features an exclusive interview with Mark DeMontis , ...
(Date:12/19/2014)... Injectable drug users who also use cocaine and amphetamines ... substance users, a new study finds. "We know ... suicide attempt and completed suicide," Didier Jutras-Aswad, a psychiatry ... university news release. "However, there are many different profiles ... substance users were actually more likely to attempt suicide." ...
Breaking Medicine News(10 mins):Health News:The 13th Annual Twin Cities DI Day Now On Video 2Health News:The 13th Annual Twin Cities DI Day Now On Video 3Health News:Cheap Prom Dresses Online Now at Sweetdressy.com 2Health News:SuperCloset Continues to Innovate with New Complete Indoor Grow Room Packages, The SuperClone Rooms are the Newest Addition to the Award Winning SuperRoom Lineup 2Health News:Mark DeMontis, Founder of Courage Canada, shares his passion for bringing hockey to those affected by blindness in Mediaplanet’s “Vision and Hearing” campaign 2Health News:Cocaine, Amphetamines May Up Injection Drug Users' Suicide Risk 2
... in the district to ensure polio drops are given to ... two suspected cases of the disease were reported last month. ... Secretary and the district Chief Medical Officer M P Singh ... Sundaram said today., ,Authorities have spent around Rs 6 ...
... second opinions on mammogram images, which show some suspicious looking ... order to speed up the process, researchers from Duke University ... useful information from a mammogram database in three seconds flat., ... every image of breast cancer in a computer database, the ...
... in the age of 40 to 50 years are more ... a vital role in the disease because of the inflammation ... new study has examined the role played by estradiol, the ... and how it works in the development of osteoarthritis. The ...
... virus that has left a deadly trail of death ... adopted by the the Bill & Melinda Gates Foundation. ... geographic reach and threatens several billion people on the ... program at Seattle-based Program for Appropriate Technology in Health ...
... in their hormones once they start parenting, say scientists ... ,Yevgenia Kozorovitskiy and her colleagues from Princeton University studied ... that live in trees - that had become fathers, ... ,The species is rare among mammals in that fathers ...
... of stores has planned to put NHS general practioner and ... the Alliance UniChem Private Limited //Company to become Alliance Boots ... Boots stores in London are already providing NHS Chlamydia-testing services. ... medical association (BMA) saying that this is a scheming move ...
Cached Medicine News:Health News:Google-Like Model Used To Diagnose Suspicious Breast Masses Quickly 2Health News:Knee Osteoarthritis May Be Triggered By Low Levels Of Estrogen 2Health News:Gates Foundation Adopts Fight against Encephalitis 2Health News:Gates Foundation Adopts Fight against Encephalitis 3
... The PowerPac HV high-voltage power supply, with temperature ... output of 5,000 V, 500 mA, and 400 ... gel temperature between 0 and 90 degrees C ... data transfer. Power cord and instructions are provided. ...
... power supply, 100-120 and 220-240 ... V, 4-400 mA, and 75 ... built-in switch when using either ... power cord. Power cord and ...
... Ultrapure MB Grade PRODUCT SPECIFICATIONS Form: Granular, free-flowing ... to 0.05 Gel Point (3%): less than or equal ... to 75C Gel Strength (3%): greater than or equal ... equal to 10% Sulfate: less than or equal to ...
Agarose L03 is recommended for separations of DNA fragments = 1,000 bp....
Medicine Products: