Navigation Links
Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

MOUNTAIN VIEW, Calif., Jan. 18, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting.  In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

"We appreciate the FDA's review of the first NDA for our novel Staccato technology and we are working to address issues raised in the Complete Response Letter," said Thomas B. King, Alexza President and CEO.  "Based on the guidance received in our End-of-Review meeting, we believe all of the issues raised in the CRL are resolvable.  We plan to resubmit the AZ-004 NDA in July 2011."

As reported in October 2010, the FDA stated in the CRL that their primary clinical safety concern was related to data from the three Phase 1 pulmonary safety studies with AZ-004.  This concern was primarily based on observed, dose-related post-dose decreases in forced expiratory volume in one second, or FEV1, a standard measure of lung function, in healthy subjects and in subjects with COPD and asthma.  The Agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004.  

In the information package submitted to the FDA in response to the CRL and in preparation for the End-of-Review meeting, Alexza presented evidence that the placebo device is saf
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
2. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
3. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
4. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
5. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
6. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
7. Alexzas Staccato® Nicotine Licensed to Cypress Bioscience
8. Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference
9. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
10. Alexza to Announce 2010 Second Quarter Financial Results on Monday, July 26, 2010
11. Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... Calif. , Aug. 27, 2014 /PRNewswire-iReach/ -- ... response system design, blended emergency medical training and ... (automated external defibrillator) training from the Department ... Army Reserve 81 st Regional Support ... and Investigations contract includes nationwide CPR/AED/First Aid training. ...
(Date:8/27/2014)... Auxilium Pharmaceuticals , Inc. (NASDAQ: AUXL ), ... certain members of the executive management team will participate ... September 8-10, 2014 in New York ... President, is scheduled to present an overview of the ... on Wednesday, September 10, 2014. The presentation ...
(Date:8/27/2014)... NEW YORK and LONDON , Aug. ... market research solutions, MarketResearch.com is pleased to announce ... Information Medical Devices Knowledge Center. The ... hosting the latest market research in the healthcare ... of reports from industry expert, Kalorama Information, published ...
Breaking Medicine Technology:Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 2Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 3Auxilium Pharmaceuticals, Inc. To Present At The Morgan Stanley Healthcare Conference 2Auxilium Pharmaceuticals, Inc. To Present At The Morgan Stanley Healthcare Conference 3MarketResearch.com: New Medical Devices Research Reports Added to Kalorama Information Knowledge Center 2MarketResearch.com: New Medical Devices Research Reports Added to Kalorama Information Knowledge Center 3
(Date:8/27/2014)... Georgia State University’s Center for ... $600,000 grant from the Maternal and Child Health ... to support implementation of the Autism Plan for ... youth with autism spectrum disorder. , In preparing ... Advisory Council composed of key stakeholders from across ...
(Date:8/27/2014)... especially when your infant looks at you and babbles. ... by listening and responding, they let their infants know ... sounds and using language more quickly. , That,s according ... and Indiana University that found how parents respond to ... communicate and use vocalizations. , The findings challenge the ...
(Date:8/27/2014)... For nearly two decades, audiences around the world ... Deva Premal & Miten with their rapturous Nepali flute ... album in May, their 2014 MANTRAS FOR LIFE TOUR ... globe, including Russia, Ukraine, Israel, Australia, the U.S., Canada, ... new album and a new five-piece band, the love ...
(Date:8/27/2014)... 27, 2014 The American Brain ... of the 2014-2016 Basic Research Fellowships and 2014-2015 Discovery ... the ABTA is seeding the field with talented, bright ... understanding of the causes, effects, diagnosis and treatment of ... scientific committee based on the potential to advance the ...
(Date:8/27/2014)... While many scientists are trying to prevent the ... autophagy, researchers at Virginia Commonwealth University Massey Cancer ... that causes the process to culminate in cell ... targets the p62 protein, which is often referred ... role in disposing unwanted cellular proteins during autophagy. ...
Breaking Medicine News(10 mins):Health News:Center for Leadership in Disability Awarded $600,000 Grant to Improve Services for Georgia’s Children and Youth with Autism 2Health News:Parents, listen next time your baby babbles 2Health News:Parents, listen next time your baby babbles 3Health News:Deva Premal & Miten's Mantras For Life Tour Announced 2Health News:Deva Premal & Miten's Mantras For Life Tour Announced 3Health News:American Brain Tumor Association Awards New Research Grants to Best and Brightest Investigators 2Health News:American Brain Tumor Association Awards New Research Grants to Best and Brightest Investigators 3Health News:Promising new cancer therapy uses molecular 'Trash Man' to exploit a common cancer defense 2
... already known to predict heart disease may also indicate ... a new Johns Hopkins study. ,C-reactive protein, or ... of CRP have been linked to higher risks of ... and diabetes. Researshers hypothesized that inflammation could play a ...
... legs syndrome is an irritating feeling of uneasiness, tiredness and ... can be painful // and often worsen at night. ... called restless legs syndrome. Studies on restless legs syndrome are ... to look at the prevalence and factors related to restless ...
... source of radiation exposure to the general population. Although ... also believed exposure during the test is responsible for ... to calculate the risk of cancer from exposure to ... and Cancer Research in the United Kingdom conducted the ...
... blood may predict the risk of heart attack or death ... new study. ,Researchers conducted a study to determine whether ... for death or non-fatal heart attack in patients with acute ... factor family and it acts as an instigator of hardening ...
... cancer accounts for the largest number of new cancer ... an international study found the survival rate of non-small-cell ... adjuvant chemotherapy. Cisplatin is an anti-neoplastic medication that interferes ... growth and spread in the body. ,As ...
... percent of diabetics take the proper preventative measures ... Researchers stressed continued negligence by diabetics increases their ... coronary heart disease, stroke, and lower extremity amputations. ... years or older, who had been diagnosed with ...
Cached Medicine News:Health News:Blood Marker Found To Predict Colon Cancer 2
This product is for the lower body and uses a Convective Warming System which is both soft and comfortable. Constructed of 2-ply material consisting of polyethylene film inner layer and non-woven out...
The torso blanket is designed to affix to the lower abdominal area and cover the upper half of the body....
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
CritiCool™ offers precise cooling to the programmed target temperature by applying temperature control algorithm....
Medicine Products: