Navigation Links
Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
Date:12/7/2010

MOUNTAIN VIEW, Calif., Dec. 7, 2010 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration (FDA) in December to discuss the Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for AZ-004 (Staccato loxapine).  Alexza has submitted an Information Package to the FDA in preparation for the meeting, with the responses or proposals to the issues raised in the CRL.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

The Company anticipates the FDA meeting will be a comprehensive review of the issues identified by the FDA in the CRL, and Alexza's planned responses to those issues.  The Company's primary meeting goal is to clarify and fully understand the key issues, and to establish a plan to respond to those issues.  While the CRL follow-up meeting will be held in December, the Company does not expect the official FDA meeting minutes to be available until at least late January 2011.  The Company anticipates providing a further U.S. regulatory update on AZ-004 after receipt of the official FDA correspondence.

Alexza also announced today that it has met with the European Medicines Agency (EMA) and has received written confirmation that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under the centralized registration procedure.  In addition, Alexza has been notified of the Rapporteur and Co-Rapporteur appointments for the AZ-004 review.  The Company believes that the comprehensive clinical development program for AZ-004 meets the requirements for the MAA filing.  Alexza expects to submit the MAA mid-year 2011.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals
'/>"/>

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:4/30/2015)... 30, 2015  Accuray Incorporated (Nasdaq: ARAY ... agreement with MIM Software Inc. to further develop ... and CyberKnife ® product portfolios. The new software ... This is Accuray,s second collaboration with MIM; the ... first iPad-based treatment plan review capability, PlanTouch™. ...
(Date:4/30/2015)... -- Thoratec Corporation (NASDAQ: THOR ), a world leader ... restore failing hearts, said today it will participate in ... on Thursday, May 14. D. Keith ... an update on the company, beginning at 10:40 a.m., ... The presentation will be available through the conference ...
(Date:4/30/2015)... Corporation (Nasdaq: DRRX ) announced today financial results ... $4.8 million and net loss was $4.9 million for ... to total revenues of $6.3 million and net loss ... 31, 2014.At March 31, 2015, we had cash and ... of $34.9 million at December 31, 2014.  Subsequent to ...
Breaking Medicine Technology:Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 3Thoratec Presentation At Bank Of America Merrill Lynch Healthcare Conference To Be Webcast 2DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 2DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 3DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 4DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 5DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 6DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 7DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 8DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 9
... THOUSAND OAKS, Calif. and NEW YORK, May 25, 2011 ... Inc. (NYSE: PFE ) today announced new ... body of evidence supporting the efficacy and safety profile ... the United States (U.S.). Eighteen abstracts across four indications, ...
... May 25, 2011 Boston Scientific Corporation (NYSE: ... U.S. Food and Drug Administration (FDA) to market its 2.25 ... in vessels as small as 2.25 mm in diameter.  The ... The PROMUS Stent features a thin-strut, open-cell design ...
Cached Medicine Technology:Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 2Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 3Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 4Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 5Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 6Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 7Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 8Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 9Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 10Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 11Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 12Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions 13Boston Scientific Announces FDA Approval and U.S. Launch of PROMUS® 2.25 mm Everolimus-Eluting Coronary Stent System 2Boston Scientific Announces FDA Approval and U.S. Launch of PROMUS® 2.25 mm Everolimus-Eluting Coronary Stent System 3Boston Scientific Announces FDA Approval and U.S. Launch of PROMUS® 2.25 mm Everolimus-Eluting Coronary Stent System 4
(Date:5/1/2015)... 02, 2015 IDLife LLC, a health ... to announce the addition of its newest partner and ... life long athlete, growing up in gymnastics and competitive ... by becoming a personal trainer and helping others achieve ... of several TV shows highlighting her stunning physique and ...
(Date:5/1/2015)... Pioneer Millworks, the largest reclaimed wood ... their reclaimed wood products at the 27th annual International ... in NYC this May. Their newest offerings, Vat 35, ... texture and color to North America's platform for global ... and color in the design world and we're excited ...
(Date:5/1/2015)... Royal River Natural Foods, a locally-owned independent natural ... study that found two natural nutrients, glucosamine and chondroitin, ... as well as standard drug treatment after six months ... The report is part of the May 2015 issue ... Royal River Natural Foods publishes for free each month ...
(Date:5/1/2015)... 2015 TROY Healthcare Solutions is proud ... User Group (RUG) Conference in Atlanta, GA from May ... Group Conference provides a forum for client-to-client presentations, continuing ... aspects of electronic medical record operations, as well as ... , In addition to sponsoring the event, TROY Healthcare ...
(Date:5/1/2015)... May 01, 2015 Hope For The ... of Hope For The Warriors® and military families. All ... support Hope For The Warriors®, a national nonprofit dedicated ... unit, and restoring hope for our service members and ... All American Ford collected and matched small autograph fee ...
Breaking Medicine News(10 mins):Health News:IDLife LLC Announces New Partnership with Fitness Celebrity, Jen Widerstrom 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 3Health News:New Study Finds Nutrients Ease Arthritis Pain, Retailer Reports 2Health News:TROY Healthcare to Exhibit at the Cerner Southeast Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner Southeast Regional User Group Conference 3Health News:All American Ford Presents Donation to Nonprofit Hope For The Warriors 2
... geographical areas in Southeast England according to a new study ... Health . The study shows that the occurrence of cervical ... Currin and her colleagues at the Thames Cancer Registry of ... cancer diagnosed between 2001 and 2005 in London, Kent, Surrey ...
... and programming in Canadian long-term care facilities fall short ... , Led by professor of Community Health and Epidemiology ... is the first comprehensive examination of these resources and ... that vulnerable long-term care residents be protected from largely ...
... 19 Esphera3 International (E3I) is a broad ... of "Patient Focused Care." Currently engaged in multiple ... of a partnered care health approach including operational ... financial operations of healthcare.E3I and its channel partners ...
... SHELBY TOWNSHIP, Mich., Feb. 19 Dr. Brett Kotlus ... Allure Medical Blog to share information,about new ... their practice. "I find that patients at our ... to sort through the tremendous,amount of information available on ...
... save lives and reduce disability, but less than 3% of ... (HealthDay News) -- A powerful clot-busting drug approved by the ... in 1996 is still rarely used in Medicare patients, new ... 495,000 admissions for stroke at the 4,750 hospitals evaluated were ...
... Insulet Corporation, (Nasdaq: PODD ), the leader ... Management System, announced plans to release its financial results ... Thursday, March 5, 2009 after the close of the ... 5:00 p.m. Eastern Time on Thursday, March 5, 2009 ...
Cached Medicine News:Health News:Infection prevention falls short in Canadian long-term care facilities 2Health News:Esphera3 International Founded on 'Patient Focused Care' 2Health News:Your Doctor Has a Blog 2Health News:Your Doctor Has a Blog 3Health News:Few Stroke Patients Get Clot-Busting Drug 2Health News:Few Stroke Patients Get Clot-Busting Drug 3
... extends that easy, breezy, beautiful image to ... an array of stylish colors, trendy shapes, ... is designed to target the broad demographics ... affordability,and high-quality, fashionable frames. The Cover Girl ...
The license agreement for the manufacturing and distribution of Bulgari eyewear was signed by Luxottica Group in 1997.,Bulgari eyewear is designed for sleek, select people who want to distinguish the...
... Brook Brothers and Luxottica Group dates ... materials and a slender line, the ... features of the style of this ... style and affordable to everyone that ...
... Ray-Ban brand debuted in 1937 with the ... was added to Luxottica Group's brand portfolio ... show business celebrities since day one, Ray-Bans ... far the best-selling sunglasses in the world. ...
Medicine Products: