Navigation Links
Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
Date:12/14/2009

MOUNTAIN VIEW, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND for Staccato loxapine was filed with the FDA in August 2005.

"AZ-004 has delivered a predictable and consistent safety and efficacy profile in treating patients with agitation," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza. "We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients' desire for quickly and comfortably gaining control, and the clinicians' goal of rapidly and reliably calming an agitated patient."

"The data we have seen from the Staccato loxapine trials are compelling," said Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX. "The product exhibits a rapid and predictable reduction in agitation, and appears to have a favorable safety profile in these patient populations."

"We once again exceeded our corporate goal timeline with the AZ-004 NDA submission," said Thomas B. King, President and CEO of Alexza. "The continued concentrated effort of the entire Alexza team throughout 2009 has been nothing short of remarkable and allowed us to complete this landmark milestone for the company. We eagerly look forward to 2010, as we work toward the approval of this product candidate."

"When Alexza was founded, I had the vision that its proprietary technology had the potential to improve the therapeu
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alexza Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
2. Alexza to Announce 2009 Third Quarter Financial Results and Update Its AZ-004 NDA Status on Monday, November 9, 2009
3. Alexza Pharmaceuticals to Present at the Fourth Annual JMP Securities Healthcare Focus Conference
4. Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
5. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
6. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
7. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
8. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
9. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
10. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/26/2015)... , March 26, 2015  The Burzynski ... a study independently conducted by the Department of ... Japan have been published. The ... 5-fluorouracil hepatic arterial infusion as post-operative adjuvant therapy ... metastasis of the liver. A ...
(Date:3/26/2015)... , March 26, 2015 Huntington Memorial ... Valley to perform transcatheter aortic valve replacement (TAVR), a ... is a revolutionary new way to replace an aortic ... a heart lung machine. The procedure is ... led by Azhil ( Alex) Durairaj , MD, interventional ...
(Date:3/26/2015)... 26, 2015  OncoGenex Pharmaceuticals, Inc. (NASDAQ: ... developments and announced fourth quarter and year end ... and Anticipated Near-term MilestonesCustirsen , Collaboration: ... negotiate the termination of their collaboration and return ... termination agreement are ongoing. , Two Phase ...
Breaking Medicine Technology:Huntington Memorial Hospital Performs Groundbreaking Minimally Invasive Replacement of Heart Valves 2OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 2OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 3OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 4OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 5OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 6OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 7OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2014 8
(Date:3/28/2015)... Emergency Medical Care (EMC), a New York ... commemorated its three-year anniversary of being the only 24/7 ... 24-hour urgent care, Emergency Medical Care offers its clients ... Emergency Medical Care’s Urgent Care NYC services ... injuries, ear infections, fevers, insect bites, burns, animal bites, ...
(Date:3/28/2015)... NV (PRWEB) March 28, 2015 One ... re-injury, according to research presented today at the American ... Day. The study examined the long term success of ... , “We examined survey data from 242 patients who ... author Justin P. Roe, MBBS, FRACS, from North Sydney ...
(Date:3/28/2015)... 2015 Andrew Hawley of Vintage Rock Posters ... concert posters. The Who and the Doors played together at ... 1968. According to Hawley, “The Who toured the United States ... college campuses. Perhaps the most famous Who poster was a ... the Doors on August 2, 1968 at the Singer Bowl ...
(Date:3/28/2015)... (PRWEB) March 28, 2015 Designers and ... new overlay entitled Scratches 5K from Pixel Film Studios. ... effects to any media inside Final Cut Pro X” ... Corporate saves time and is an effective tool for ... FCPX Overlay Scratches 5K's intuitive grunge overlays. Simply drag ...
(Date:3/27/2015)... March 27, 2015 The Monogamy ... dating experts Samantha Sanderson and Jason Rogers has just ... of media attention. The commotion surrounding the course's launch ... him to publish an in-depth review of the new ... the men in their lives suddenly start pulling away ...
Breaking Medicine News(10 mins):Health News:Emergency Medical Care Celebrates Three Years of 24/7 Walk-In Urgent Care Services 2Health News:Young Athletes at Greater Risk for Re-Injury after ACL Surgery 2Health News:Avid Collector from Vintage Rock Posters, Inc. Announces His Search For Original 1960's Who Psychedelic Concert Posters. 2Health News:Pixel Film Studios Unveiled Scratches 5k for Final Cut Pro X Editors 2Health News:The Monogamy Method - Review Of Samantha Sanderson & Jason Rogers' Relationship Program Released 2
... all current services, invest $20 million in facility ... ... Oct. 31 Prime Healthcare Services,Inc. (PHS), the owner and ... that Prime Healthcare Centinela, one,of its subsidiaries, has acquired Centinela ...
... Memorial Health,Services (MHS), a not-for-profit health care ... announced today that it has selected,Integrated Healthcare Holdings, ... IHHI, a partially physician-owned publicly traded hospital ... County with a total of,770 beds, 2787 employees ...
... /PRNewswire-FirstCall/ - DRAXIS Health Inc.,(TSX: DAX) (Nasdaq: DRAX ... of directors that he will retire as the President ... 2007. Dr. Barkin joined the senior management of ... been instrumental in guiding the Company through,a period of ...
... Oct. 31 Always Best Care Senior,Services has expanded ... Living Placement Service, and Personal Response Company, is,proud to ... Always Best Care,Senior Services for outstanding care. For over ... our work - a sincere concern for,the betterment of ...
... Cogon Systems, Inc.,has completed deployment of the health ... South Florida Health Information Initiative (SFHII).,Authorized physicians and ... session will be able to log onto the ... organizations. Built using the Community MOMENT OF ...
... Systems, Inc. has been,awarded a Research, Development, Test ... Advanced Technology Research Center (TATRC) to,develop advanced clinical ... The primary goal of the project is to ... to deliver clinical decision support,through rapid retrieval of ...
Cached Medicine News:Health News:Prime Healthcare Services Acquires Centinela Hospital Medical Center 2Health News:Prime Healthcare Services Acquires Centinela Hospital Medical Center 3Health News:Prime Healthcare Services Acquires Centinela Hospital Medical Center 4Health News:Memorial Health Services Announces Sale of Anaheim Memorial Medical Center 2Health News:DRAXIS Health Inc. Announces Retirement of Dr. Martin Barkin as President and Chief Executive Officer 2Health News:DRAXIS Health Inc. Announces Retirement of Dr. Martin Barkin as President and Chief Executive Officer 3Health News:DRAXIS Health Inc. Announces Retirement of Dr. Martin Barkin as President and Chief Executive Officer 4Health News:Announcing Always Best Care Senior Services Expansion Into San Diego, California 2Health News:South Florida HIE Phase II Completed and Phase III Awarded 2Health News:U.S. Army Selects Cogon Systems to Develop Advanced Clinical Decision Support Tools for Hand Held Computers 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: