Navigation Links
Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

MOUNTAIN VIEW, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from its second Phase 3 clinical trial of AZ-004 (Staccato(R) loxapine). This Phase 3 clinical trial was conducted in patients with bipolar disorder experiencing acute agitation. Both the 5 mg and 10 mg doses of AZ-004 met the primary endpoint of the trial, which was a statistically significant reduction in agitation from baseline to the 2-hour post-dose time point, compared to placebo. AZ-004 is an inhalation product candidate being developed for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.

"Alexza initiated this second Phase 3 clinical trial of our lead program in late July, completed enrollment in less than three months, and today we are reporting positive top-line results for the primary and secondary endpoints," said James V. Cassella, PhD, Alexza Senior Vice President, Research and Development. "These very strong results -- coupled with the positive data from our first Phase 3 trial in schizophrenic patients -- reinforce our belief that AZ-004 is a potentially important new drug candidate for treating acute agitation. Loxapine is a well established antipsychotic and the Staccato system enables patients to easily and painlessly self-administer the drug with a single breath and achieve therapeutic effect as quickly as an intravenous injection -- a combination of attributes that makes AZ-004 a unique potential therapeutic alternative for the acute treatment of agitation. We look forward to taking the next steps toward preparing an NDA for submission in early 2010."

Phase 3 Clinical Trial Design


'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
2. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
3. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
5. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
8. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
9. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
10. TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
11. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2015)... Minn. , June 30, 2015  EnteroMedics Inc. ... devices that use neuroblocking technology to treat obesity, metabolic ... its previously announced public offering  of 40,229,886 units. Each ... of a Series A warrant to purchase one share ... warrant to purchase one share of common stock, at ...
(Date:6/30/2015)... June 30, 2015  Isis Pharmaceuticals, Inc. (NASDAQ: ... 2015 Annual Meeting of StockholdersWhen:Tuesday, June 30 at 5:10 ... the Internet.  Simply log onto our website listed above. ... during the live event, a replay of the webcast ... www.isispharm.com . ABOUT ISIS PHARMACEUTICALS, INC. ...
(Date:6/29/2015)... , June 29, 2015  Daktari Diagnostics was honored ... the Technology in the Service of Society Award. IEEE President ... Barry L. Shoop presented the award to Principal ... The ceremony was held Saturday, June 20, 2015, at the ... . "I have spent more than ...
Breaking Medicine Technology:EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 2EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 3Webcast Alert: Corporate Presentation at the 2015 Isis Pharmaceuticals Annual Stockholder Meeting 2Webcast Alert: Corporate Presentation at the 2015 Isis Pharmaceuticals Annual Stockholder Meeting 3Daktari Honored with IEEE Spectrum Award 2
... leading provider of medical scrubs, is now accepting nominations through ... . The award provides the nation an opportunity to recognize ... duty to make a difference for their patients and the ... 9,000 healthcare professionals have been nominated for the award. To ...
... 2011 Wako Diagnostics, a division of Wako Chemicals ... and Drug Administration (FDA) to market the uTASWako i30 ... in vitro diagnostic (IVD) tests in the ... use by healthcare professionals as an aid in the ...
Cached Medicine Technology:Cherokee Inspired Comfort Award Calls for Healthcare Professional Nominations 2Cherokee Inspired Comfort Award Calls for Healthcare Professional Nominations 3Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the uTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment. 2
(Date:6/30/2015)... EAGAN, Minn. (PRWEB) , ... June 30, 2015 , ... ... $1.5 million in funding for 24 projects across the state. The projects improve community ... Grants range from $25,000 to $100,000 and many are renewable for a second year ...
(Date:6/30/2015)... Ohio (PRWEB) , ... June 30, 2015 , ... ... services nationwide, is pleased to announce it’s own Debby Mann, CPC, RCC, ROCC, ... Association (RBMA) Radiology Summit with the Special Recognition Award for her contribution to ...
(Date:6/30/2015)... ... 30, 2015 , ... The LIV Fertility Center in Puerto Vallarta ... right age to pursue egg freezing. Statistics show that 20 percent of women are ... 150 percent increase since the 1970s. , Sadly, for women who have delayed parenthood ...
(Date:6/30/2015)... ... June 30, 2015 , ... The American Lung Association in ... media event in San Diego. Speakers and clean air advocates included San Diego County ... Germuska of Kindred Hospital, and Daniel Sullivan, founder and president of Sullivan Solar Power. ...
(Date:6/30/2015)... (PRWEB) , ... June 30, 2015 , ... ... nationwide, announces today that they have been awarded the exclusive billing agreements with ... full range of billing services encompassing their proprietary suite of billing process software ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota Foundation Awards $1.5 Million 2Health News:ADVOCATE’s Debby Mann Honored With Special Recognition Award 2Health News:LIV Fertility Center Educating Women on the Critical Timing of Egg Freezing 2Health News:LIV Fertility Center Educating Women on the Critical Timing of Egg Freezing 3Health News:LIV Fertility Center Educating Women on the Critical Timing of Egg Freezing 4Health News:LIV Fertility Center Educating Women on the Critical Timing of Egg Freezing 5Health News:Local Dignitaries Gather to Announce San Diego’s Clean Air Challenge 2Health News:Local Dignitaries Gather to Announce San Diego’s Clean Air Challenge 3Health News:ADVOCATE Wins Billing Agreements with Jackson Radiology Associates 2
... , , , ... Los Angeles today announced that Caroline W. Nahas, managing director of ... the new volunteer chair of the organization,s corporate board of directors. ... served in this important role. Nahas will replace outgoing board chair, ...
... four sites across the country to participate in a new ... the effectiveness of a chemotherapeutic agent, ThermoDox, used in conjunction ... recurrent chest wall breast cancer. Recurrent chest wall ... the chest wall, most commonly presenting in the skin overlying ...
... ... tips on keeping kids healthy and active this summer , ... Minneapolis, MN (PRWEB) July 20, 2009 -- On soccer fields ... enjoy the summer sun. While the occasional bump or bruise is expected and normal, some ...
... , NAPERVILLE, Ill., July 20 The ... that Maryjane A. Wurth, 53, Chief Operating Officer, Healthcare Association of ... of IHA. Wurth succeeds Ken Robbins, who has served as IHA ... assume her duties as IHA,s president in October. , ...
... to view smoking-related content, study shows, , MONDAY, July 20 ... isn,t watching TV shows or movies that glamorize smoking, he ... the Internet, particularly from popular social networking sites such as ... 20 in Pediatrics , found that the Internet is ...
... , CAMP HILL, Pa., July 20 Highmark Blue Shield ... Health Conference, set for Saturday, Aug. 29 from 6:30 a.m. until 3 ... and University Drive in Hershey, Pa. , , ... a greater hand in their health by attending Fun, Fit & Fabulous! ...
Cached Medicine News:Health News:Caroline W. Nahas Named New Corporate Board Chair for United Way of Greater Los Angeles 2Health News:Caroline W. Nahas Named New Corporate Board Chair for United Way of Greater Los Angeles 3Health News:RI Hospital first in country to enroll patient in new study for recurrent chest wall breast cancer 2Health News:Treating Kids' Summertime Bumps, Bruises and Injuries with The Healthcare Scoop 2Health News:Treating Kids' Summertime Bumps, Bruises and Injuries with The Healthcare Scoop 3Health News:Maryjane A. Wurth Named New President of Illinois Hospital Association 2Health News:Internet May Be Newest Venue for Teen Tobacco Exposure 2Health News:Internet May Be Newest Venue for Teen Tobacco Exposure 3Health News:Feel Fun, Fit & Fabulous! At the 2009 Women's Health Conference 2Health News:Feel Fun, Fit & Fabulous! At the 2009 Women's Health Conference 3
The URCA (Uric acid) method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of uric acid in serum, plasma and urine....
For the quantitative in vitro determination of apolipoprotein A-1 (apo A-1) in serum and plasma. For use as an aid if assessing the risk of coronary artery disease....
The GGT method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of g-glutamyl transferase activity in serum and plasma...
For the quantitative in vitro determination of Triglycerides in serum and plasma....
Medicine Products: