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

tic value of drugs," said Alejandro C. Zaffaroni, PhD, Chairman Emeritus and Co-Founder of Alexza. "It is splendid that Alexza has reached its first NDA so quickly and is on the doorstep of its first Staccato-based product, Staccato loxapine."

AZ-004 Clinical Results Summary

The AZ-004 NDA contains efficacy and safety data from more than 1600 patients and subjects who have been studied in thirteen different clinical trials. In 2008, the Company successfully initiated and completed two pivotal Phase 3 clinical trials. In these studies, both doses of AZ-004 (5 and 10 mg) met the primary and key secondary endpoints of the studies, with highly statistically significant reductions in agitation, as compared to placebo. Additionally, the 10 mg dose of AZ-004 exhibited a rapid onset of effect, with statistically significant reductions in agitation at 10 minutes post-dose, the first time point measured. The reduction of agitation was sustained through the 24-hour study period. In both studies, the administration of AZ-004 was generally safe and well tolerated.

In 2009, Alexza initiated and completed five non-pivotal safety and NDA-supporting studies for AZ-004. Alexza believes these data, along with data from the other efficacy and safety trials conducted with AZ-004, adequately demonstrate the efficacy and safety of AZ-004 for the proposed indication.

Agitation Market Opportunity

Episodes of agitation afflict many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the United States, and bipolar disorder, which affects approximately 5.7 million adults in the United States. More than 90% of these patients will experience agitation in their lifetime.

Agitation generally escalates over time with patients initially feeling uncomfortable, tense and restless. As the agitation intensifies, their behavior
'/>"/>

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:9/30/2014)... , N.J. and NEW BRUNSWICK, N.J., Sept. 30, 2014 ... agreement that allows Kessler Foundation and New Jersey ... biomedical research, education and patient care programs has ... and chief executive officer of Kessler Foundation and ... Jersey Health Foundation. "The experience of ...
(Date:9/30/2014)... NEWPORT BEACH, Calif. , Sept. 30, 2014 ... prestigious accreditation of the American Association of Tissue ... Russell Cook , Chief Executive Officer. ... on-site inspection by a specially trained AATB inspector.  ... and administrative performance within the facility meets or ...
(Date:9/30/2014)... , Sept. 30, 2014 The Eastern European ... established medical-device providers as well as new medical-device manufacturers ... while simultaneously looking at ways to reduce the cost ... distributors is one of the effective means to achieve ... distribution market in Eastern European and provides profiles of ...
Breaking Medicine Technology:Kessler Foundation Partners with New Jersey Health Foundation To Start Innovative Companies To Change the Lives of People with Disabilities 2Biostructures, LLC Earns AATB Accreditation 2Medical Technologies Distributor Profiles in Eastern Europe 2Medical Technologies Distributor Profiles in Eastern Europe 3
... polls showing that 50% of Americans favor the legalization of ... taken to make that a reality. Mr. Flynt places blame ... weed: the pharmaceutical, alcohol and prison industries. Pharmaceutical ... because it means they,ll be spending less on prescription pills. ...
... TAMPA, Fla., May 3, 2012  Supported by the ... National Mobility Awareness Month commences this month ... about the many wheelchair accessible vehicles and adaptive mobility ... lifestyle. Celebrating across the United States and Canada, the ...
Cached Medicine Technology:Inaugural National Mobility Awareness Month Commences in May Saluting the More than 18 Million with Disabilities 2Inaugural National Mobility Awareness Month Commences in May Saluting the More than 18 Million with Disabilities 3
(Date:10/1/2014)... October 01, 2014 After undergoing a ... chamber of commerce to join, Living Well Assisted Living ... Commerce in Marin County, the home of its headquarters. ... the moment, and the thought of adding one more ... to keep looking for the right chamber to join ...
(Date:10/1/2014)... Angeles, CA (PRWEB) October 01, 2014 ... debut documentary film, "Beautiful Births", emerging filmmaker Jacqui Blue ... help other women discover the truth about natural birth. ... from people all over the world and has been ... birth. Many of the topics highlighted in the film ...
(Date:10/1/2014)... 2014 Indosoft, Inc., a leading provider of ... it has added support for Sangoma Lyra ... Indosoft have a history of bringing innovative products to ... offers a significant benefit to those using Asterisk as a ... available to users of Q-Suite. , In the past decades, ...
(Date:10/1/2014)... QueenBeeTickets.com is giving music fans the opportunity to purchase ... tour, which has him traveling from November 19 until December ... to view the selection of presale tickets available at ... to come out on October 14, and the tour in ... tickets are available for shows that will take place in ...
(Date:9/30/2014)... one third of medical and nursing students in developing ... own countries after graduation, while less than one fifth ... they are needed most, according to a new study. ... driving the current outbreak of Ebola in western Africa. ... three of the world,s poorest countries (Guinea, Sierra Leone ...
Breaking Medicine News(10 mins):Health News:Living Well Joins San Rafael Chamber of Commerce 2Health News:Living Well Joins San Rafael Chamber of Commerce 3Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 2Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 3Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 4Health News:Indosoft Announces Q-Suite Support For Sangoma Lyra 2Health News:Bob Seger Presale Tickets: QueenBeeTickets.com Delights Fans with Discounted Tickets for All 20 Stops on Seger’s “Ride Out” Tour with The Silver Bullet Band 2Health News:Developing countries should enroll medical and nursing students from rural areas 2Health News:Developing countries should enroll medical and nursing students from rural areas 3
... , , EXTON, Pa., ... ViroPharma Incorporated (Nasdaq: VPHM ) today announced that the ... of Generic Drugs (OGD) draft guidelines on bioequivalence (BE) for Vancocin(R) ... life-threatening bacterial infections of the gastrointestinal (GI) tract, Clostridium difficile ...
... ... versus Goliath struggle raging in the West, joins the stellar line-up at the ... and in Los Angeles (August 7 - 13). The film will also air ... Impact series on Planet Green, a network of Discovery Communications.,Split Estate maps a ...
... , , , ... (Nasdaq: CLRT ), a premier anatomic pathology and molecular testing ... results for the second quarter and six months ended June 30, 2009. ... second quarter of 2009 versus the second quarter of 2008, and a ...
... EAST RUTHERFORD, N.J., Aug. 4 Cambrex Corporation (NYSE: CBM ) ... Highlights , , Sales ... Reported sales declined by 9.8% for the quarter. , EBITDA ... year (see attached table). , Debt, net of cash was ...
... and MISSISSAUGA, ON, Aug. 4 /PRNewswire-FirstCall/ - Covidien (NYSE: ... products, and Nuvo Research Inc. (TSX:NRI), a Canadian drug ... Drug Administration (FDA) has set a new action date ... Pennsaid (diclofenac sodium) topical solution 1.5% w/w of November ...
... , WALTHAM, Mass., Aug. 4 Inverness ... leader in enabling individuals to take charge of their health ... management, today announced that it intends to offer $150 million ... of the notes will be guaranteed by certain of Inverness, ...
Cached Medicine News:Health News:ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride 2Health News:ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride 3Health News:ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride 4Health News:Premier of Split Estate at DocuWeeks 2009 to Call National Attention to Urban Drilling in New York and Los Angeles 2Health News:Premier of Split Estate at DocuWeeks 2009 to Call National Attention to Urban Drilling in New York and Los Angeles 3Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 2Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 3Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 4Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 5Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 6Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 7Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 8Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 9Health News:Clarient Reports Second Quarter Revenue Up 40 Percent 10Health News:Cambrex Reports Second Quarter 2009 Results 2Health News:Cambrex Reports Second Quarter 2009 Results 3Health News:Cambrex Reports Second Quarter 2009 Results 4Health News:Cambrex Reports Second Quarter 2009 Results 5Health News:Cambrex Reports Second Quarter 2009 Results 6Health News:Cambrex Reports Second Quarter 2009 Results 7Health News:Cambrex Reports Second Quarter 2009 Results 8Health News:Cambrex Reports Second Quarter 2009 Results 9Health News:Cambrex Reports Second Quarter 2009 Results 10Health News:Cambrex Reports Second Quarter 2009 Results 11Health News:Cambrex Reports Second Quarter 2009 Results 12Health News:FDA extends review of Pennsaid(R) diclofenac sodium topical solution 2Health News:FDA extends review of Pennsaid(R) diclofenac sodium topical solution 3Health News:Inverness Medical Innovations, Inc. Announces Offering of $150 Million of Senior Notes 2
The STAAR ELASTIC LENS®, is a single piece silicone lens to be placed completely in the capsular bag....
... Lomb SoFlex™ UV-Absorbing, Silicone Posterior ... to be used for primary ... of aphakia in patients 60 ... where a cataractous lens has ...
Liberty Three Piece PMMA Lens with UV Absorber....
Single piece Anterior Chamber PMMA lens, AC depth: 4.9....
Medicine Products: