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

2-hours post-dosing.

The duration of the clinical benefit of AZ-004, as measured by the need for additional study drug and/or rescue medication by the 4-hour time point, was significantly different between drug and placebo, and appeared to be dose related. Compared to the 64% of the placebo group that required more than one dose of the study drug and/or rescue medication, 40% of the 5 mg group (p = 0.0019) and only 25% of the 10 mg group (p < 0.0001) required more than one dose of study drug and/or rescue medication. A similar statistically significant pattern was evident for the 24-hour time point.

A responder analysis was conducted using the CGI-I scale. A responder was defined as having a CGI-I score at 2 hours after the first dose of either a 1 (very much improved) or 2 (much improved). Both the 5 mg (66% responders; p < 0.0001) and 10 mg (74% responders; p < 0.0001) doses of AZ-004 were statistically superior to placebo (28% responders).

Safety Evaluations

Side effects were recorded throughout the study period. The administration of AZ-004 was generally safe and well tolerated. There were no serious adverse events. The only common side effect reported (> 10% in any treatment group) was taste (dysgeusia). This side effect was rated as mild in all patients and occurred in both drug and placebo dose groups.


                       Treatment Emergent Side Effects
                        (> 2% in any treatment group)

                              Placebo      5 mg AZ-004   10 mg AZ-004
    Term                      (n=105)         (n=104)        (n=105)
    Dysgeusia                    6%             17%            17%
    Sedation / Somnolence        3%              7%             6%
    Dizziness                    8%              6%             5%
    Throat irritation            1%              0%             4%
    Fatigue                     
'/>"/>
SOURCE  Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

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:12/15/2009)... 15 Rib-X Pharmaceuticals, Inc., a company ... novel drugs for the treatment of serious multi-drug-resistant ... collaborative research agreement with Massachusetts General Hospital (MGH). ... the collaboration, Dr. David Hooper of MGH will ... animal model to determine resistance development and to ...
(Date:12/15/2009)... Arlington Medical Resources (AMR) and Decision ... (MRSA) is the most concerning pathogen to surveyed ... treatment of skin and skin structure infections. A ... factors that influences European physician drug selection for ... factors that drive prescribing include an agent,s skin ...
(Date:12/15/2009)... /PRNewswire-Asia/ -- Sinovac Biotech Ltd. ( SVA),a ... announced today,that Weidong Yin, Chairman, President & ... to be one of 18 nominees for ... CCTV,s Economic Man-of-the-Year is the country,s ... to as the "Oscar Award of the,Chinese ...
Breaking Medicine Technology:Rib-X Pharmaceuticals Enters into Collaborative Agreement on Delafloxacin with Massachusetts General Hospital 2Rib-X Pharmaceuticals Enters into Collaborative Agreement on Delafloxacin with Massachusetts General Hospital 3A Drug's Activity Against MRSA is Among the Top Factors That Influences European Physician Antibiotic Selection for Treating Skin and Skin Structure Infections 2A Drug's Activity Against MRSA is Among the Top Factors That Influences European Physician Antibiotic Selection for Treating Skin and Skin Structure Infections 3Sinovac's CEO Weidong Yin Nominated for China Central Television's Prestigious Economic Man-of-the-Year Award 2Sinovac's CEO Weidong Yin Nominated for China Central Television's Prestigious Economic Man-of-the-Year Award 3September is Prostate Cancer Awareness Month 54295 1September is Prostate Cancer Awareness Month 54295 2Biostar Pharmaceuticals Inc to Host Fiscal Year 2009 Second Quarter Earnings Conference Call on Friday August 14 2009 at 10 3A30 a m EDT 13519 1Biostar Pharmaceuticals Inc to Host Fiscal Year 2009 Second Quarter Earnings Conference Call on Friday August 14 2009 at 10 3A30 a m EDT 13519 2Biostar Pharmaceuticals Inc to Host Fiscal Year 2009 Second Quarter Earnings Conference Call on Friday August 14 2009 at 10 3A30 a m EDT 13519 3Cellular Dynamics International Appoints Leroy Hood M D Ph D and George Church Ph D to its Scientific Advisory Board 13518 1Cellular Dynamics International Appoints Leroy Hood M D Ph D and George Church Ph D to its Scientific Advisory Board 13518 2Cellular Dynamics International Appoints Leroy Hood M D Ph D and George Church Ph D to its Scientific Advisory Board 13518 3Cellular Dynamics International Appoints Leroy Hood M D Ph D and George Church Ph D to its Scientific Advisory Board 13518 4
... April 1 The Michael J. Fox Foundation ... up to $6.5 million in total funding available ... accelerate solutions to some of the most difficult ... for PD.The Critical Challenges funding opportunities focus research ...
... PRUSSIA, Pa., March 31 Successful and seamless completion ... to randomized patients, market research, an effective recruitment strategy, ... President and CEO Liz Moench notes: "This is achievable ... meet timelines." She adds, "We had great team chemistry ...
Other Medicine Technology:Michael J. Fox Foundation Commits up to $6.5 Million in Funding for Critical Challenges in Parkinson's Disease 2Michael J. Fox Foundation Commits up to $6.5 Million in Funding for Critical Challenges in Parkinson's Disease 3Major Restless Legs Study Completes Enrollment With Support From MediciGlobal 2
(Date:12/15/2009)... Medicare for consultations how will they get paid for patient ... understand terms. , ... Washington, DC ... will eliminate consultation codes. These codes are what healthcare ... seen for a medical consultation, whether in a provider’s office ...
(Date:12/15/2009)... Ford Health System Joins the influx of Healthcare Organizations Partnering ... ... Hazlet, N.J. (PRWEB) December 15, 2009 -- iCIMS, ... solutions , announced today that Henry Ford Health Systems has ... talent management needs. Henry Ford joins more than 30 other ...
(Date:12/15/2009)... to announce the release of a new report titled, “Incontinence ... for clinical devices used to treat and manage urinary incontinence. ... ... 15, 2009 -- Marketstrat is pleased to announce the release ... The report specifically addresses world markets for clinical devices used ...
(Date:12/15/2009)... Dec. 15, 2009 UT Southwestern Medical ... to date of the unique observable characteristics seen ... syndrome. , The findings, reported online and in ... Clinical Endocrinology and Metabolism, suggest that patients ... lumped together with those diagnosed with two similar ...
(Date:12/14/2009)... The combination of AQUALIPO™ and NaturalFill™ revolutionary new liposuction and ... wrinkling, and plump lips all in one minimally invasive treatment. ... ... -- The combination of AQUALIPO™ and NaturalFill™ can remove excess ... and lips to help people slim down, reduce facial wrinkling ...
Breaking Medicine News(10 mins):Health News:Medicare Eliminates Consultation Codes for Doctors 2Health News:iCIMS Emerges as Talent Management Solution of Choice for Henry Ford Health Systems 2Health News:iCIMS Emerges as Talent Management Solution of Choice for Henry Ford Health Systems 3Health News:iCIMS Emerges as Talent Management Solution of Choice for Henry Ford Health Systems 4Health News:Urinary Incontinence Rates Increase Worldwide As Awareness Grows About Treatment Options: Urethral Slings Are Popular Alternatives When Medications Fail 2Health News:Urinary Incontinence Rates Increase Worldwide As Awareness Grows About Treatment Options: Urethral Slings Are Popular Alternatives When Medications Fail 3Health News:Researchers ID traits of people with rare accelerated aging syndrome 2Health News: Free Webinar Series at Aqualipo.com Shows How New Combination Liposuction/Fat Transfer Treatment Helps Patients Slim Down and Reduce Facial Wrinkling 2Health News: Free Webinar Series at Aqualipo.com Shows How New Combination Liposuction/Fat Transfer Treatment Helps Patients Slim Down and Reduce Facial Wrinkling 3
... Two-dozen members,of the Army,s 2nd Battalion, 113th Infantry ... getting ready for their upcoming,deployment in Iraq. Instead ... a Lasik procedure that allows them to have ... ), Drs. Joseph and Jeffery Dello ...
... Airlift first by private organizations into Chengdu, STAMFORD, ... Chinese earthquake victims provided by private organizations left,Kansas City ... part of the shipment. AmeriCares is proud to play ... Province., "It will take many years for the ...
... recent study shows that pre-operative assessments of patients with ... and successful treatment of lymphedema. , The study, conducted ... National Institutes of Health (NIH) and in collaboration with ... published in the journal, Cancer (April 25, 2008). ...
... CAN HELP REVERSE MENTAL ACUITY DEFICITS IN SMOKERS ... to Address FAA,Ruling on Smoking Cessation Product, ... Federal Aviation,Administration (FAA) that it has removed a ... medications for pilots and air-traffic,controllers, it,s important to ...
... cells from embryonic stem cells, find clues to predict response ... liver cells have been generated from embryonic stem cells using ... screen for harmful side effects of new drugs before they ... reports on advances against liver diseases that were presented this ...
... Journal of Ultrasound in Medicine (JUM) includes an ... Potential Bioeffects of Diagnostic Ultrasound, which addresses issues ... is intended for use in assessing its risks ... that provide extensive evaluations of 5 bioeffects categories: ...
Other Medicine News:Health News:Soldiers Receive Free Memorial Day Lasik Surgery Before Going to Iraq 2Health News:AmeriCares Ships Medicines and Medical Supplies to Earthquake Victims in China 2Health News:New study shows positive role physical therapists play in lymphedema diagnois and treatment 2Health News:MultiVu Video Feed: FREE NICOTINE REPLACEMENT THERAPY (NRT) TO BE OFFERED TO REGISTERED PILOTS INTERESTED IN QUITTING RELIEF IN LIGHT OF RECENT FAA RULINGS 2Health News:New Hope for Liver Diseases 2Health News:New Hope for Liver Diseases 3
The CIC Pro Clinical Information Center brings together vital patient information from multiple monitoring devices....
... integrates drug infusion,with patient monitoring and ... modular platform. With multiple configuration,options, you ... you,need them, keeping the number of ... while managing the unique needs of,each ...
... of infusion pumps are designed ... series of administration sets. The ... a wide variety of needleless ... featuring the patented Flo-Stop® Device ...
... These specialty Eraser instruments have ... surgeon with the right tool for ... introduced a series of 25 gauge ... provide discrete treatment of target tissues ...
Medicine Products: