Navigation Links
Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
Date:9/2/2008

5 mg dose was not statistically tested at the time points other than the 2-hour time point, as per the statistical analysis plan, but the mean changes in PEC scores demonstrated a dose response at all time points.

A dose response pattern for AZ-004 was also apparent, as measured by the need for a patient to require more than one dose of study drug by the 4-hour post-first dose time point. Compared to the 44% of the placebo group that required more than one dose of the study drug, only 25% of the 10 mg group (p = 0.0039) and 32% of the 5 mg group (p = 0.085) required more than one dose of study drug.

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 (57% responders; p = 0.0015) and 10 mg (67% responders; p < 0.0001) doses of AZ-004 were statistically superior to placebo (36% responders).

Safety Evaluations

Side effects were recorded throughout the clinical trial period. The administration of AZ-004 was generally safe and well tolerated. The most common side effects reported (> 10% in any treatment group) were taste (dysgeusia), dizziness, sedation and headache. These side effects were generally mild to moderate in severity, 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=115) (n=116) (n=113)

Dysgeusia 3 % 9 % 11 %

Dizziness 10 % 5 % 11 %

Sedation 10 % 13 % 11 %

Oral

Hypoaesthesia 0 % 1 % 4 %

Headache 14 % 3 % 3 %'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
2. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
3. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
4. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
5. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
6. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
7. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
8. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
9. Calabar AB Today Announced New Financing for Continuation of the Phase II Program in Patients With Dry Mouth
10. Intercell Announces Initiation of Further Phase II Clinical Trial of V710 an Investigational Vaccine to Prevent S. aureus Infection
11. Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... HARRISBURG, Pa. , Jan. 14, 2014 Dynamic Healthcare ... ("GMH"), announced today that it acquired Progressive Home Medical Equipment, ... January 7, 2014. The terms of the acquisition were not ... medical equipment ("DME") company providing a wide range of sleep, ...
(Date:1/14/2014)... 14, 2014 Animal Emergency Critical Care, a LifeCentre partner practice, ... is the first in Loudoun County ... Dr. Susan M. Barnes , Medical Director, is a ... Dr. Cole Taylor , are avid scuba divers. "As altitude ...
(Date:1/14/2014)... 2014 NineSigma , Inc., the leading innovation ... Leadership Summit , May 14-16, 2014 at the Global ... . This is the premier ... breakthrough achievements through open innovation. Participants will learn how ...
Breaking Medicine Technology:Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 2Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 3Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 4
... than doubled time without tumor growth and reduced the ... with placebo- Only once-daily oral cancer treatment to directly ... tumor cell division and blood vessel growth- Phase III ... additional cancersEAST HANOVER, N.J., March 30 Novartis announced ...
... Laboratory Response Network (LRN), the national laboratory system charged ... its first decade at its national meeting in Orlando, ... of Public Health Laboratories (APHL), the Centers for Disease ... Investigation (FBI) to test for agents of bioterrorism, the ...
Cached Medicine Technology:Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 2Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 3Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 4Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 5Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 6Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 7Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib 8Nation's Laboratory Response Network Marks First Decade of Protecting Public Health 2
(Date:7/9/2014)... Infectious Diseases (NIAID), part of the National Institutes ... of CRS3123, an investigational oral antibiotic intended to ... ) infection. CRS3123 (previously known as REP3123) is ... while sparing normal intestinal bacteria. , The Phase ... men and women ages 18 to 45 in ...
(Date:7/9/2014)... labels handed out by pharmacists may be misread ... according to new research by the University of ... Blind)., The study, published recently in the ... prescription medications dispensed by pharmacies do not consistently ... simply following recommended guidelines for font size, use ...
(Date:7/9/2014)... A study published in the scientific journal ... Bonin, two researchers at Universit Laval, reveals that it ... method that involves rekindling pain so that it can ... means to alleviate chronic pain. , The researchers from ... universitaire en sant mentale de Qubec (IUSMQ) were inspired ...
(Date:7/8/2014)... similar longevity and cardiovascular health as other healthy mature ... American Journal of Transplantation . The findings may ... the transplant professionals caring for them. , Over the ... 55 years and older has become more common. Given ... disease, the removal of a kidney could make older ...
(Date:7/8/2014)... team of clinicians from Plymouth, UK, and Sydney, Australia, ... July Australia) launched ACEmobile - a free-to-use app to ... ACEmobile is the first of its kind; an iPad-based ... provides support through the whole process, meaning more members ... this type of assessment. Designed by clinicians for clinicians, ...
Breaking Medicine News(10 mins):Health News:NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection 2Health News:Most prescription labels fail to meet guidelines, risking dosage errors 2Health News:Discovery of a new means to erase pain 2Health News:Study finds kidney donation safe for healthy older adults 2Health News:New app widens opportunities for dementia assessments 2Health News:New app widens opportunities for dementia assessments 3
... - The New England Regional Spinal Cord Injury Center ... a Spinal Cord Injury Model System (SCIMS) by the ... grants are awarded in five-year cycles by the NIDRR ... sites. NIDRR supports innovative research in the delivery, ...
... Oct. 27 (HealthDay News) -- Americans need to take action ... Thursday. Someone in the world dies of a stroke ... every year. That number is about equivalent to the population ... Centers for Disease Control and Prevention. The agency,s message ...
... Ontarians 65 years and older did not see a dentist ... and a reduced quality of life , a new study ... the Institute for Clinical and Evaluative Sciences (ICES) shows. , ... and affect a person,s ability to chew and digest food ...
... attack (TIA), sometimes referred to as a "mini stroke", were ... first year if their care was co-ordinated by a special ... published in the November issue of the European Journal ... Neurology at Aarhus University Hospital in Denmark studied 306 patients ...
... News) -- Older people who walk more slowly than ... and disability following surgery, according to a new study. ... should assess the elderly differently than younger patients and ... "This approach may lead to a more individualized ...
... has found that a childhood behavioral intervention to lower ... increase consumption of foods that are good sources of ... levels and lower systolic blood pressure when study participants ... for publication in The Endocrine Society,s Journal of ...
Cached Medicine News:Health News:U.S. Health Officials Urge Lifestyle Changes to Cut Stroke Risk 2Health News:Nearly half of Ontario seniors do not see dentists regularly 2Health News:Hospital team significantly reduced risk of further vascular events after 'mini strokes' 2Health News:Hospital team significantly reduced risk of further vascular events after 'mini strokes' 3Health News: Slower Walking Speed Linked to Surgical Risk in Elderly 2Health News: Slower Walking Speed Linked to Surgical Risk in Elderly 3Health News:Childhood diet lower in fat and higher in fiber may lower risk for chronic disease in adulthood 2
Toxoplasma IgM II ELISA....
HSV 1 & HSV 2 DFA Test....
Herpes Simplex Virus 2 IgG ELISA....
Herpes Simplex Virus 1 IgG ELISA....
Medicine Products: