Navigation Links
Alexza Announces the Adasuve™ (Staccato® Loxapine) PDAC Meeting Date of December 12, 2011
Date:10/24/2011

MOUNTAIN VIEW, Calif., Oct. 24, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed.  In August 2011, Alexza received notification that the FDA had accepted the resubmission of the ADASUVE NDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.

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.)

Adasuve™ (Staccato loxapine), Alexza's lead program, is being developed for the acute treatment of agitation in adults with schizophrenia or bipolar disorder.  Alexza completed and announced positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA in December 2009.  In October 2010, the Company received a Complete Response Letter (CRL) from the FDA regarding the application.  The Company completed an end-of-review meeting with the FDA in December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April 2011.  The ADASUVE NDA was resubmitted on August 4, 2011, and has a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.

In October 2011, the Company established a commercial partnership for ADASUVE with Grupo Ferrer International, S.A.  Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and is Alexza's partner in the registration, distribution and promotion of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.  Alexza plans to file the ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the fourth quarter of 2011.

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

Safe Harbor Statement

This press release contains 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 potential of the Company's ADASUVE 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 ADASUVE 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 Pharmaceuticals to Present at the 18th Annual NewsMakers in the Biotech Industry Conference
2. Alexza and Grupo Ferrer Establish Partnership for the Commercialization of Adasuve™ (Staccato® Loxapine) in Europe and Latin America
3. Alexza Pharmaceuticals to Present at the Sixth Annual JMP Securities Healthcare Conference
4. Alexza Announces Adasuve™ (Staccato® Loxapine) PDUFA Goal Date of February 4, 2012
5. Alexza Announces Resubmission of AZ-004 (Staccato® Loxapine) NDA
6. Alexza to Announce 2011 Second Quarter Financial Results on Monday, August 8, 2011
7. Alexza Reports 2011 First Quarter Financial Results and Provides Business Update
8. Alexza to Present at the MDB Bright Lights Conference 2011
9. Alexza Prices $16.1 Million Registered Direct Offering
10. Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
11. Alexza to Announce 2010 Year-End Financial Results on Tuesday, March 15, 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... 24, 2016  Joe Marziani has joined VMS BioMarketing as senior vice president of ... In his new role, Marziani will lead the company,s business development and sales team, ... outcomes. Photo - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
(Date:5/24/2016)... -- Open Access Journal Focusing on ... Elsevier , a world-leading provider of scientific, technical ... launch of Clinical Neurophysiology Practice ... clinical practice issues in clinical neurophysiology. The journal will ... and didactic reviews. It is an official journal of ...
(Date:5/23/2016)... PUNE, India , May 23, 2016 ... is spread across 163 pages, profiles 12 companies and ... 280 tables and figures on the industry and its ... study that is comprehensive in nature, details the current ... of the industry including definitions, classifications, applications and industry ...
Breaking Medicine Technology:
(Date:5/24/2016)... ... 24, 2016 , ... United Benefit Advisors (UBA), the nation’s ... Austin & Co., Inc. Headquartered in Albany, New York, Austin & Co., ... technology, and beyond. As an employee-owned company celebrating over 160 years of ...
(Date:5/24/2016)... ... May 24, 2016 , ... How to Write Error ... NC, http://www.fdanews.com/humanerrordrugdevice , Human error is known to be the major cause ... error will ever be totally eliminated, many human performance problems can be prevented. , ...
(Date:5/24/2016)... ... (PRWEB) May 24, 2016 -- ... of its Advisory Board. Joining the Grow Healthy Advisory Board ... of them embody the mission of our organization and bring talent, ... have them as we continue to expand our footprint as the ...
(Date:5/24/2016)... ... 2016 , ... Backed by decades of experience, Metroloji Okulu ... the best suited solution to meet regulatory requirements. Their professional staff also performs ... Istanbul. , Metroloji Okulu specializes in MadgeTech’s line of medical and pharmaceutical ...
(Date:5/24/2016)... Mateo, CA (PRWEB) , ... May 24, 2016 ... ... dedicated to advancing the science and clinical practice of radiosurgery, is recognizing five ... of stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). The awards will be ...
Breaking Medicine News(10 mins):