Navigation Links
Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
Date:4/29/2008

MOUNTAIN VIEW, Calif., April 29 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from a Phase 1 clinical trial of AZ-007 (Staccato(R) zaleplon). AZ-007 is an inhalation product candidate being developed for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep.

"This is the fifth product candidate using our single-dose Staccato technology platform that has completed a Phase 1 clinical trial," said James V. Cassella, PhD, Senior Vice President of R&D at Alexza. "We have again shown that the Staccato system can deliver IV-like pharmacokinetics, even with water insoluble compounds, in a simple, easy-to-use, one-breath device. We were pleased with the initial results. As we continue our analysis of the data collected in this study, we plan to present these data in scientific and medical forums at future dates, and determine the next steps for this product candidate."

Phase 1 Clinical Trial Results

The AZ-007 Phase 1 clinical trial enrolled 40 healthy volunteers at a single U.S. clinical center. The purpose of this trial was to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double blind, randomized, dose-escalation trial design, 4 doses of AZ-007 (ranging from 0.5 to 4.0 mg) were compared to placebo.

AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the 4 doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation assessed on a 100 mm visual-analog scale, s
'/>"/>

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

0

GOOD

Page: 1 2 3 4

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. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
6. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
9. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
10. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
11. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/4/2009)... Dec. 4 Drs. Neal Shore and E. David ... the additional analysis of secondary end points of biochemical ... FIRMAGON® (monthly degarelix for injection) or monthly leuprolide in ... Prostate cancer patients who received FIRMAGON 240/80 mg/month ...
(Date:12/4/2009)... AstraZeneca (NYSE: AZN ) today announced that ... once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as ... Depressive Disorder (MDD). SEROQUEL XR is the only medication ... both major depressive disorder as adjunctive therapy and acute ...
(Date:12/3/2009)... NEW YORK, Dec. 3 Guidepoint Global, LLC , ... their Sleep Apnea Tracker, a monthly longitudinal data release that ... Sleep Apnea market. ,, The Sleep Apnea Tracker captures ... sold in the United States from 15 different equipment providers ...
Breaking Medicine Technology:Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial 2Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial 3Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial 4US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 2US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 3US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 4US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 5US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 6US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 7US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 8US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder 9Leading Primary Research Firm Guidepoint Global Announces Launch of Sleep Apnea Tracker 2Apollo Health Street Collaborates with Client to Develop a CCHIT Certified 08 Ambulatory EMR 48571 1Apollo Health Street Collaborates with Client to Develop a CCHIT Certified 08 Ambulatory EMR 48571 2Norman Brinker Honored With 2009 Methodist Health System Folsom Leadership Award 48569 1Norman Brinker Honored With 2009 Methodist Health System Folsom Leadership Award 48569 2Norman Brinker Honored With 2009 Methodist Health System Folsom Leadership Award 48569 3Norman Brinker Honored With 2009 Methodist Health System Folsom Leadership Award 48569 4Industry Partners Step Up To Help Blood Cancer Patients 48567 1Industry Partners Step Up To Help Blood Cancer Patients 48567 2
... vitro microbiology and proof of concept in topical ... March 2007 - Arpida Ltd.,(SWX: ARPN) today announced ... against a large panel of,clinical isolates, including those ... of AR-2474 were found,to be highly effective in ...
... Texas, March 8, 2007--The World Health Organization,has ... cases are rising in,Pakistan. , So is ... constantly,claim, the pharmaceutical industry is denying important ... According to London’s Guardian,newspaper, “parents of ...
Other Medicine Technology:Arpida adds novel antibiotic AR-2474 to its preclinical pipeline 2Arpida adds novel antibiotic AR-2474 to its preclinical pipeline 3Why Is Polio Spreading in Pakistan? 2
(Date:12/6/2009)... A new study provides welcome news for patients ... (VTE). , The condition is estimated to impact ... when an abnormal clot forms in a vein and ... In some cases, the clot may detach from its ... the lungs, causing a potentially fatal condition known as ...
(Date:12/6/2009)... and members of the community, in cooperation with the Greater VA ... holiday party. This year,s attendance is expected to soar to more ... , ... (PRWEB) December 6, 2009 -- Volunteer organizations ... Healthcare System in West Los Angeles, will once again create a ...
(Date:12/5/2009)... a phase 1/2 clinical trial that it is ... newly diagnosed with multiple myeloma, a cancer of white ... Cancer Institute. , Partial responses or better were seen ... drug combination in the multi-center study, with 74 percent ... phase 2 population, reports Paul G. Richardson, MD, of ...
(Date:12/5/2009)... Dec. 5 ,, What: Cuts for ... difference in the fight against cancer and other terminal illnesses ... be donated to St. Jude Children,s Research Hospital. Guests will ... a delectable and savory Vietnamese restaurant in Falls Church for ...
(Date:12/5/2009)... Is Most Challenging-- ,, PHILADELPHIA and NEW ... genes, dubbed partner genes, that fuse with another gene ... By more accurately defining specific partner genes, researchers expect ... treatments. ,, Oncologists also aim to use this ...
Breaking Medicine News(10 mins):Health News:New drug shows promise for those with clotting disorders: McMaster researcher 2Health News:17th Annual Event Honoring 5,000 + Veterans, Military Personnel to Include Real Life “Heroes” 2Health News:17th Annual Event Honoring 5,000 + Veterans, Military Personnel to Include Real Life “Heroes” 3Health News:Multiple myeloma patients experience high response rate with new 3-drug combination 2Health News:New Gene Findings Will Help Guide Treatment in Infant Leukemia 2Health News:New Gene Findings Will Help Guide Treatment in Infant Leukemia 3Health News:New Gene Findings Will Help Guide Treatment in Infant Leukemia 4
... melanoma when diagnosed by a dermatologist has a higher survival ... specialist will be able to detect// the tumor in its ... of survival. ,Individuals whose melanoma is diagnosed by ... and to survive five years than those with melanoma diagnosed ...
... from the researchers from Yale School of Medicine and ... first time found evidence of a// molecular mechanism that ... ,This discovery may help the development of ... and for cognitive changes in schizophrenia, bipolar disorder, or ...
... It may be an embattled country, what with Israel, Hizbollah ... ,But the thirst to look 'more beautiful' seems to remain ... National Bank has come forward to offer easy loans for ... surgery loans' as a way to 'have the life you've ...
... found that the use of remote monitoring for ... to significantly// improve clinical outcomes (mortality, morbidity and ... monitoring (telephone support or telemonitoring) to electronically transfer ... weight and ECG and oxygen details, to their ...
... seniors and others with Medicare to make the most of ... of Health and Human Services (HHS) and the Centers for ... Healthier US Starts Here. , It ... Medicare Prevention tour bus will visit each of the 48 ...
... of delivering drugs to fight cancers - by transporting ... be less// physically traumatic to patients, the team said ... of Singapore's department of chemical and biomolecular engineering believe ... under a standard microscope, are the delivery key. ...
Other Medicine News:Health News:Chances of Survival for Melanoma is High When Detected by Dermatologists 2Health News:New Light on Working of Brain Networks 2Health News:New Light on Working of Brain Networks 3Health News:Loans for Cosmetic Surgery in Lebanon 2Health News:Research Uncovers the Significant Benefits of Remote Monitoring 2Health News:Seniors Encouraged To Make Use Of Medicare’s Freebie 2
EC+ Extra Care Bariatric Bed...
... Excel Care ES bed is especially designed ... empowered, while protecting the caregivers who manage them. ... the most routine tasks pulling up in ... to caregivers and disheartening for patients. Excel Care ...
... Disposable Prefilled 28%-100% FIO 2 500ML 0.45% ... nebulizers provide unmatched performance and ease of use. ... adjustable from 28% to 100% FIO 2 . ... water for inhalation, USP; 0.45% sodium chloride inhalation, ...
... Nebulizer Disposable Prefilled 28%-100% FIO 2 ... ,Our prefilled nebulizers provide unmatched performance and ... cool high-output aerosols adjustable from 28% to 100% ... of solutions: sterile water for inhalation, USP; 0.45% ...
Medicine Products: