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:9/4/2015)... VANCOUVER, British Columbia and MENLO ... DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the ... commercialization of new cancer therapies, today announced its financial ... and provided an overview of recent Company highlights and ... will host a business update conference call and live ...
(Date:9/3/2015)... , Sept. 3, 2015  Cipla, a global pharmaceutical ... everyday needs of all patients, today announced that its ... to acquire two US-based companies, InvaGen Pharmaceuticals Inc., and ... closing conditions, is valued at $550 million and will ... these transactions is over $200 million for the year ...
(Date:9/3/2015)... Sept. 3, 2015 Report Details ... Which areas are going to grow at the fastest ... to 2025, assessing data, trends, opportunities and prospects there. ... and graphs. Discover the most lucrative areas in the ... lets you assess forecasted sales at overall world market ...
Breaking Medicine Technology:DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 2DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 3DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 4DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 5DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 6DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 7DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 8Cipla to acquire 100% of generic businesses in US for $550M 2Cipla to acquire 100% of generic businesses in US for $550M 3Cipla to acquire 100% of generic businesses in US for $550M 4Cipla to acquire 100% of generic businesses in US for $550M 5Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 2Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 3Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 4
... June 27, 2011 Pepto-Bismol announced today that for the ... red, white and … PINK? In an act of true ... the Nathan,s Famous Fourth of July International Hot Dog Eating ... To make this contest a celebration to remember, Pepto-Bismol ...
... China, June 27, 2011 /PRNewswire-Asia/ -- Shenzhen Wuzhou Changlian ... health care electronics & medical equipment, announces its new ... have become the indispensable parts for people to easily ... To cater to those patients or people ...
Cached Medicine Technology:Pepto-Bismol and Nick Cannon Heat Things up at this Year's Nathan's Famous Fourth of July International Hot Dog Eating Contest 2Pepto-Bismol and Nick Cannon Heat Things up at this Year's Nathan's Famous Fourth of July International Hot Dog Eating Contest 3New Arrivals of Exercise & Health Care Equipment 2
(Date:9/4/2015)... CA (PRWEB) , ... September 04, 2015 , ... According ... the elderly Americans currently being cared for in nursing homes and assisted living facilities ... author discussed a personal story in which her father was at one point close ...
(Date:9/4/2015)... (PRWEB) , ... September 04, 2015 , ... Mile High ... ways in which a lack of funding for sidewalks, bike paths, and other vital ... report, while the Denver region spends billions of dollars to expand public transit, there’s ...
(Date:9/4/2015)... (PRWEB) , ... September 04, 2015 , ... After wearing ... in desperate need of new apparel. In an effort to assist the team, the ... has launched a charity drive to raise funds for the new uniforms. , As ...
(Date:9/4/2015)... ... September 04, 2015 , ... San Francisco cosmetic ... CitiDent. CEREC is a newer method for creating restorations through innovative imaging equipment ... eliminating the need for multiple appointments, CEREC produces restorations with total precision for ...
(Date:9/4/2015)... ... September 04, 2015 , ... The USC Eye Institute is ... 9 nationwide by Doximity. Faculty, residents and staff are honored to have contributed ... the quality of our ophthalmology residency program. Our faculty places a high priority on ...
Breaking Medicine News(10 mins):Health News:Op-Ed about Insufficient Care for Elderly Patients Highlights the Advantages of Quality, At-Home Care, says Dr. Michael Farzam 2Health News:Op-Ed about Insufficient Care for Elderly Patients Highlights the Advantages of Quality, At-Home Care, says Dr. Michael Farzam 3Health News:Missed Connections in Metro Denver Transit 2Health News:The Jones Agency Serves Up a Charity Drive to Fund New Uniforms for the Sprayberry High School Girls Volleyball Team 2Health News:The Jones Agency Serves Up a Charity Drive to Fund New Uniforms for the Sprayberry High School Girls Volleyball Team 3Health News:San Francisco Dentist, Dr. Ben Amini, is Now Offering CEREC Technology at CitiDent 2Health News:USC Ophthalmology Residency Program Ranked in Top 10 by Doximity 2Health News:USC Ophthalmology Residency Program Ranked in Top 10 by Doximity 3
... Without knowing how much of an industrial chemical is ... if it poses any threat to the environment or human ... come up with a novel way of estimating how much ... generated, laying the groundwork for future studies to assess any ...
... 20 Intercoast College, Sierra Council on Alcoholism ... host the William Glasser Institute,s annual West Region ... the Hilton Sacramento Arden West. The conference features ... critical topics including education, public mental health, addiction ...
... Finds that Health Plans Contain Costs and Provide ... 20 Medicaid health plans are producing cost ... individuals covered by Medicaid, improving quality of care, ... to a Lewin Group report released today by ...
... May 20 The Indiana Podiatric Medical ... of that state,s podiatrists, today endorsed use ... payment solution for physicians, hospitals and other ... IPMA signed a three-year agreement with Preferred ...
... Inc., a leader in healthcare payment and cost management ... with Tempe, AZ-based HMA, Inc. to offer increased access ... customers utilizing the Beech Street primary, complementary and supplemental ... provider networks, which include, Health Management Network (HMN), the ...
... asked to share experiences with sun safety and skin cancer detection ... ... May 20, 2009 -- Summer has begun, and sunscreen is selling ... sunscreen, individuals nationwide are talking to their doctors about keeping their ...
Cached Medicine News:Health News:Novel approach estimates nanoparticles in environment 2Health News:Novel approach estimates nanoparticles in environment 3Health News:Choice Theory Education Conference: Sacramento Saturday, May 30 2Health News:Medicaid Health Plans Provide Cost Savings to States and High Quality and Value to Beneficiaries, New Analysis Shows 2Health News:Medicaid Health Plans Provide Cost Savings to States and High Quality and Value to Beneficiaries, New Analysis Shows 3Health News:Medicaid Health Plans Provide Cost Savings to States and High Quality and Value to Beneficiaries, New Analysis Shows 4Health News:Medicaid Health Plans Provide Cost Savings to States and High Quality and Value to Beneficiaries, New Analysis Shows 5Health News:Indiana Podiatric Medical Association Endorses A-Claim Payment Solution 2Health News:Viant Expands Relationship With HMA for Improved Healthcare Access in AZ 2Health News:The Healthcare Scoop Encourages Sun Safety This Memorial Day Weekend And Into Summer 2Health News:The Healthcare Scoop Encourages Sun Safety This Memorial Day Weekend And Into Summer 3
Near PT test card/illus of the ocular adnexa 5 1/2" X 8"....
It has the near point, Snellen X-CYL Jaeger & SMD cards in one set....
... Wormington NP Card is specially designed to be ... the older Rosenbaum card (as noted by Horton ... corrected. The "J" notations are not used because ... notation. Using the Wormington NP Card, the examiner ...
Standard reading test. 'It was the month of May'...
Medicine Products: