Navigation Links
Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
Date:10/11/2010

60;Because AZ-004 incorporates a novel delivery system, the CRL also included input from FDA's Center for Devices and Radiological Health (CDRH).  CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting.  CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.

"We are reviewing the Complete Response Letter and plan to meet with the FDA as soon as possible to discuss the Agency's pulmonary safety concern.  Alexza shares the agency's deep interest in patient safety, and believes the pulmonary data is supportive of the safety of AZ-004.  We look forward to discussing the appropriate way to address this issue," said Thomas B. King, Alexza President and CEO.  "We are also undertaking steps to address the other items raised in the CRL.  We appreciate the FDA's review of the first NDA for our novel Staccato technology, and we expect to work closely with FDA to resolve the issues raised in the Complete Response Letter.  Alexza continues to believe in the safety and efficacy of AZ-004 based on the comprehensive clinical development program we have conducted."

Conference Call Information

The Company will host an investor conference call and live webcast today, Monday, October 11, 2010 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time.  The conference call, live webcast and archived replay are open to all interested parties.

To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link.  Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required.  Interested parties may also pre-register to avoid pre-call delays at

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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:12/19/2014)... Dec. 18, 2014 Research and Markets ... of the "Micro Market Monitor: North American ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... progressing steadily, which has resulted in fueling the ... The main purpose of these dermatology devices is ...
(Date:12/19/2014)... Calif., Dec. 18, 2014 Capnia, Inc. ... development of medical diagnostics based on its proprietary ... flow, today announced financial results for the third ... "Following the completion of our initial ... to maximize the recently initiated CoSense® commercial launch," ...
(Date:12/19/2014)... 18, 2014 Since last month,s FBI shutdown ... known as the leading online black market for illegal ... in its offering of drugs and other illegal items.  ... takedowns did succeed in lowering the numbers of drugs ... the markets in August. But some new sites that ...
Breaking Medicine Technology:Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8Post Silk Road - Another Online Drug Den Now Dominates the DarkNet 2Post Silk Road - Another Online Drug Den Now Dominates the DarkNet 3
... BOSTON, Nov. 7, 2011 PAREXEL International Corporation (NASDAQ: ... at the Lazard Capital Markets Healthcare Conference in New York. ... making a presentation on PAREXEL at 11:30 a.m. ET on ... presenting at the Citi Small/Mid Cap Conference in Las Vegas. ...
... USA Corporation, the world,s leading provider of medical education ... healthcare industry, is proud to introduce three new ... Hysterectomy module for the LAP Mentor™ and the new ... will be demonstrated at Simbionix booth #1103 at the ...
Cached Medicine Technology:PAREXEL International to Present at Lazard Capital Markets Healthcare Conference and Citi Small/Mid Cap Conference 2Simbionix to Introduce Three New Women's Health Products 2Simbionix to Introduce Three New Women's Health Products 3
(Date:12/20/2014)... BambooIndustry.com is a leading eco-friendly bamboo flooring ... bamboo flooring promotion for the coming 2015. , ... and offers the best bamboo products and services ... all customers can enjoy a special discount, up ... BambooIndustry.com from press releases. , The bamboo flooring ...
(Date:12/20/2014)... December 20, 2014 An improving macroeconomic ... have benefited the Massage Services industry over ... of industry products, the anticipated 1.0% annualized increase in ... provided consumers with the means to afford additional massages. ... a massage in a given year has declined from ...
(Date:12/20/2014)... The print component of Healthy Aging is ... approximately 160,000 copies and an estimated readership of 420,000. ... social media strategy and across a network of top ... version of the campaign, click here . , ... ladies of CTV’s The Social. Lainey Lui, Melissa ...
(Date:12/20/2014)... 2014 The Doctor’s Office Urgent Care of ... part of a decade. They’ve treated over 40,000 patients ... healthcare alternative to the Paramus area. , ... additions to their staff of top-notch board certified physicians: Christine ... These new doctors will work tirelessly to carry ...
(Date:12/20/2014)... December 20, 2014 Atore, Inc, (San ... just launched first birthday focused portal on December 17th, ... MESSAGE” launched in both US and Japan. , MERRY ... : http://merrybirthday.net/message/ , MERRY BIRTHDAY MESSAGE is ... around the world. , Features, Choose from thousands of ...
Breaking Medicine News(10 mins):Health News:Eco-friendy Bamboo Flooring Manufacturer BambooIndustry.com Introduces Its Bamboo Flooring Promotion for 2015 2Health News:Massage Services in the US Industry Market Research Report from IBISWorld Has Been Updated 2Health News:Massage Services in the US Industry Market Research Report from IBISWorld Has Been Updated 3Health News:The ladies of The Social urge Canadian women to put themselves first over the holiday season and into the new year in Mediaplanet’s “Women’s Health” campaign 2Health News:The Doctor's Office Urgent Care Adds 3 New Physicians to Their Growing Medical Team 2Health News:Atore, Inc. Releasing the First Birthday Portal 2
... March 24 The American Cancer Society Cancer Action ... and the Campaign for Tobacco-Free Kids applaud Senator Frank ... Drug Administration to exert its authority and immediately remove ... quoted numerous times in many publications during the past ...
... emphasizes values-based curriculum PHOENIX, March 24 In answer ... the need for more values-driven leaders, Grand Canyon ... it rewards to high academic achievers as well as ... is our own higher education stimulus package," said GCU ...
... is released to educate Americans about their risk of type ... American Diabetes Alert(R) Day. The American Diabetes Association urges ... they may have it. To help educate the public, ... Partners, Liberty Medical Supply, Inc., have teamed up to provide ...
... traits, susceptibility to certain diseases , , TUESDAY, March ... copy number variations (CNVs) in the human genome of ... differences in gene copy numbers caused by deletions, duplications ... large amount of human diversity and can also be ...
... Family secrets such as alcoholism, abuse and unwanted pregnancies ... disease strikes, according to Marie-Dominique Beaulieu, a professor at ... "I see it in my practice," says Beaulieu, who ... Chair. "Family secrets lead to feelings of guilt, anger ...
... Associates, a national investment consulting firm, has expanded ... CFA, CAIA.LCG,s ownership provides significant incentive to attract ... industry. LCG rewards ownership in the Firm ... excellence and honesty.LCG Associates, Inc. provides investment consulting ...
Cached Medicine News:Health News:Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids 2Health News:Grand Canyon University Increases Academic Scholarships 2Health News:Grand Canyon University Increases Academic Scholarships 3Health News:American Diabetes Association Alert(R) Day Video - Do You Have Diabetes? 2Health News:American Diabetes Association Alert(R) Day Video - Do You Have Diabetes? 3Health News:American Diabetes Association Alert(R) Day Video - Do You Have Diabetes? 4Health News:Study IDs Variations in Black, White Genomes 2
... a cruciate sparing version which provides ... both resurfacing and inset patellas. Precision ... and fit with tibial articular surface ... cutting guide peg locations provide easy ...
The Balanced Knee System provides instrumentation designed to achieve proper tissue balancing and alignment with user-friendly instrumentation that provides reproducible results....
Advance Posterior Stabilized Total Knee systems improves patellofemoral kinematics, reduces wear rate potential, increases resistance to posterior tibial dislocation, achieves at least 120o flexion i...
... The Duracon tibial inserts have radiused ... advanced 4-axis machining, maximizing conformity of ... condyles of the femoral component. The ... the Duracon system, and accommodates the ...
Medicine Products: