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 disorder patients.  Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials and submitted the AZ-004 NDA in December 2009.  In October 2010, the Company received a Complete Response Letter, or CRL, from the FDA, regarding its NDA for AZ-004.  The Company completed an end-of-review meeting with the FDA in late December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April 2011.  Alexza believes that the AZ-004 NDA is a Class 2 resubmission and the review period will be 6 months, and that the FDA will likely present the AZ-004 application to an Advisory Committee during the review period.

For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

The anticipated news release and conference call will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the adequacy of the Company's capital to support the Company's current operations, the potential of the Company's planned AZ-004 NDA resubmission to adequately address the issues in the CRL, the timing of the FDA's review of the NDA and the eventual prospects that AZ-004 will be approved for marketing. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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:5/25/2016)... MedDay, a biotechnology company focused on the treatment ... "High doses of biotin in progressive multiple sclerosis: extension phase ... Ayman Tourbah , Principal Investigator of the Phase 3 ... Neurology (EAN) in Copenhagen, Denmark . The ... on Sunday, 29 May 2016 from 14:45 to 16:15 CEST ...
(Date:5/24/2016)... --   , ... Endpunkte und demonstriert Ebenbürtigkeit bei der Gesamtreinigung des ... guter , Reinigung des ... (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ) , ... der MORA-Studie der Phase III für NER1006 (1 ...
(Date:5/24/2016)... Celsion Corporation (NASDAQ: CLSN ... an update on its ongoing OVATION study, a ... the Company,s DNA-based immunotherapy, with the standard of ... advanced ovarian cancer who will undergo neoadjuvant chemotherapy ... IL-12 DNA plasmid vector formulated as a nanoparticle ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... More than a third of American adults are considered ... surgery has received increased attention in recent years, as an article published ... weight loss, most people are familiar with the basic requirements of maintaining a healthy ...
(Date:5/27/2016)... ... ... With over 60 percent of acute stroke survivors being left unable to ... in the rehabilitation process has steadily increased. Ekso Bionics had been working to help ... stroke. , Ekso Bionics has now received clearance from the U.S. Food and Drug ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed ... by inspiring human interest stories, courtesy of leaders in the nursing and health ... the industry, from leading advocates and associations—namely Jones & Bartlett Learning. , Jones ...
(Date:5/26/2016)... ... ... There are many ways to cook a hot dog, but new research commissioned ... dogs straight off the grill. Of the 90 percent of Americans who say they ... hot dog, far outpacing other cooking methods such as steaming (12 percent), microwaving (9 ...
(Date:5/26/2016)... , ... May 26, 2016 , ... Connor Sports, ... basketball as a partner for the Tamika Catchings Legacy Tour that will ... industry leader in hardwood basketball surfaces in all forms and levels of the game, ...
Breaking Medicine News(10 mins):