Navigation Links
Alexza Announces Resubmission of AZ-004 (Staccato® Loxapine) NDA
Date:8/5/2011

MOUNTAIN VIEW, Calif., Aug. 5, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in October 2010.  The Company believes this is a Class 2 resubmission with a six-month review cycle.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

In addition to the data from the original NDA and additional analyses of some of those data, the AZ-004 resubmission contains new data from the successfully completed human factors study, stability data from new production batches manufactured late last year, updated manufacturing and controls sections addressing findings from the Company's Pre-Approval Inspection, and updated draft labeling and a comprehensive REMS proposal.

About Alexza Pharmaceuticals, Inc.

Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenia or bipolar di
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
4. Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
5. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
8. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
9. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
10. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... , Aug. 28, 2015  CytomX Therapeutics, Inc., a ... cancer, today announced the filing of a registration statement ... Commission (SEC) relating to a proposed initial public offering ... be offered and the price range for the offering ... its common stock under the symbol "CTMX" on the ...
(Date:8/28/2015)... Research and Markets ( ... "Investigation Report on China,s Tobramycin Market, 2010-2019" report ... antibiotic whose eye drop and ointment are the most ... or inflammation caused by eye infection. Currently, dozens of ... to produce tobramycin, among which the Top 5 are ...
(Date:8/28/2015)... , Aug. 28, 2015 ... has announced the addition of the "Investigation ... to their offering. Developed by Pharmacia ... prostaglandin receptor agonist which effectively reduces intraocular pressure. ... FDA, latanoprost (under the trade name of Xalatan) ...
Breaking Medicine Technology:CytomX Files Registration Statement for Proposed Initial Public Offering 2Investigation Report on China's Tobramycin Market, 2015-2019 2China Latanoprost Market Investigation Report 2015-2019 2
... Dec. 14, 2010 Samplify Systems, Inc., a ... the ultrasound market, is pleased to announce that ... has won Electronic Design Magazine,s Best ... category.  Details of Samplify,s AutoFocus™ beamforming technology currently ...
... 14, 2010 Pacira Pharmaceuticals, Inc. ... the New Drug Application (NDA) for EXPAREL™, a long-acting ... filing by the U.S. Food and Drug Administration (FDA). ... the initial indication of postsurgical analgesia by local administration. ...
Cached Medicine Technology:Samplify's AutoFocus™ Beamforming Technology Awarded Electronic Design's 'Best of 2010' 2
(Date:8/31/2015)... ... August 31, 2015 , ... GenHart Software, LLC, a rising player in ... small businesses operate as efficiently and cost effectively as possible, with a belief that ... their first year of operation – and the Charleston business community is taking notice. ...
(Date:8/30/2015)... , ... August 31, 2015 , ... Avid collector Andrew ... the Doors Shrine Auditorium concert posters. This hand colored artwork is one of the ... in Los Angles. Hawley states, "When the doors played the Shrine, the band ...
(Date:8/30/2015)... DE (PRWEB) , ... August 31, 2015 , ... ... exhibitor at the AHCA/NCAL 66th Annual Convention & Expo October 5th & 6th ... and organizations together, the AHCA/NCAL convention brings industry professionals from all over the ...
(Date:8/30/2015)... (PRWEB) , ... August 30, 2015 , ... ... across platforms and devices, today announced it is a Silver Sponsor of the ... at Sky City Convention Centre in Auckland, NZ. Throughout the event, AvePoint will ...
(Date:8/30/2015)... ... ... Natural Rest contains a unique mixture of vitamins and herbs that are ... to improve mood disorders and anxiety. Like all other Creative Medical Health products, Natural ... regenerative medicine conducted by Dr. Amit Patel of the University of Utah, one of ...
Breaking Medicine News(10 mins):Health News:GenHart Software, LCC Launches Scheduling, Appointment Reminder, Text Marketing Software Designed to Help Businesses Increase Revenue While Decreasing Client Attrition 2Health News:GenHart Software, LCC Launches Scheduling, Appointment Reminder, Text Marketing Software Designed to Help Businesses Increase Revenue While Decreasing Client Attrition 3Health News:Intellitec Solutions to feature Microsoft Dynamics GP at AHCA/NCAL 66th Annual Convention & Expo 2Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 2Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 3Health News:AvePoint Showcases the Future of Enterprise Collaboration as Silver Sponsor of the Digital Workplace Conference in New Zealand 4Health News:Creative Medical Health’s Natural Rest® Now Available on ReCreative Medical Health’s Natural Rest® Now Available on RevNutrition.com 2
... woman who comes to a health care centre does increase ... partners, a new study confirms. The study, led by ... at St. Michael,s Hospital, represents a major reversal of thinking ... or intimate partner violence. Until now, the research and ...
... around 2 billion dollars a year on remediation at ... used for groundwater monitoring. Yet according to Rolf Halden, ... information gathered is often of limited value. Under ... Department of Defense, Halden, assistant director at the Institute,s ...
... -- The sooner rehabilitation begins after knee replacement, the ... In the study, published March 7 in the ... than 150 patients who began rehabilitation within 24 hours ... of patients who began rehabilitation 48 to 72 hours ...
... , FRIDAY, March 4 (HealthDay News) -- In what experts ... have for the first time turned human embryonic stem cells ... of brain cell that,s lost to Alzheimer,s disease. The ... cholinergic" (BFC) neurons, is key to the progression of Alzheimer,s. ...
... Walter and Eliza Hall Institute have identified the key ... response. The finding could have wide-ranging repercussions for ... and change how the efficacy of newly developed drugs ... Erika Cretney, Dr Axel Kallies and Dr Stephen Nutt ...
... Sledding is the most common cause of injury among winter ... list of the top five injury-causing winter activities. "More ... States due to sledding. More than 30 percent are head ... specialist at Gottlieb Memorial Hospital in Melrose Park, Ill., part ...
Cached Medicine News:Health News:Universal screening programs can uncover abuse, study finds 2Health News:Monitoring waste in groundwater (without all the waste) 2Health News:Scientists Use Stem Cells, Skin Cells to Create Brain Cells Lost to Alzheimer's 2Health News:Scientists Use Stem Cells, Skin Cells to Create Brain Cells Lost to Alzheimer's 3Health News:Scientists Use Stem Cells, Skin Cells to Create Brain Cells Lost to Alzheimer's 4Health News:Newly identified cell population key to immune response 2
Cold light source single outlet....
... The 4150S is a state ... halogen light source with an ... standard coupler to connect optical ... source distinguishes itself from all ...
The 9300XSP is the brightest light source available. Visualize more clearly, see color more accurately, and work more effectively. Luxtecs xenon lighting delivers bright, white light that is as close...
The Carl Zeiss Head-worn Loupes L and LC are the ideal solution if a low magnification suffices for your work and you want to keep your hands free to perform the task at hand....
Medicine Products: