Navigation Links
Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Date:7/24/2008

eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they have acute agitation at the time of patient randomization. This study is the first AZ-004 study enrolling bipolar disorder patients. Alexza projects that this second Phase 3 clinical trial will take approximately 12 months to complete patient enrollment.

The primary endpoint for the study is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, measured at 2 hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period.

About Acute Agitation

Acute agitation, characterized by unpleasant arousal, tension, irritability and hostility, is one of the most common and severe symptoms of many major psychiatric disorders, including schizophrenia and bipolar disorder. According to the National Institute of Mental Health (NIMH), bipolar disorder affects about 5.7 million American adults while schizophrenia afflicts about 2.4 million people in the United States. Market research among physicians and health-care providers indicates that over 90% of these patients will experience agitation during their lifetime and that about 70% of those who experience agitation will have one to six episodes per year.

Agitated patients are often treated in an emergency department, and are also treated as in-patients in psychiatric hospitals or psychiatric units in standard hospitals. Market research among psychiatrists indicates that these physicians currently treat acute agitation with intramuscular (IM) injections, rapid-dissolve tablets or standard tablets. IM injections are invasive,
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
2. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
3. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
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. Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
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. Alexza Completes Target Enrollment in AZ-104 Phase 2a Clinical Trial in Migraine Patients
11. Taligen Therapeutics Initiates Corporate Growth Plan with Appointment of Abbie Celniker, Ph.D., as CEO and Establishment of Cambridge, Mass., Headquarters
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... You,re visiting the dentist for what you ... or she says you need a root canal. Though ... have several questions and feel apprehensive about your upcoming ... nothing to worry about. The Pennsylvania Dental Association (PDA) ... anxiety the public may have surrounding this common procedure ...
(Date:12/19/2014)... Breckenridge Pharmaceutical, Inc. announced today that it ... Pvt. Ltd. ( Hyderabad, India ) under ... ANDAs.  Under the terms of the agreement, MSN will ... for the U.S. market, and Breckenridge will market and ... have agreed to develop an oral antibiotic with current ...
(Date:12/19/2014)... 19, 2014 In today,s increasingly global ... presence to reflect the needs of a global ... meet the needs of key stakeholders while recognizing ... According to recent research by benchmarking firm, ... participating companies averaged more than $100,000 in annual ...
Breaking Medicine Technology:Root Canals Have Become More Routine 2Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Building a Best-in-Class Pharma Global Brand Website 2
(Date:12/19/2014)... 2014 Eufaula, Oklahoma, located just 9 ... the state’s largest lake with more than 600 miles ... to a little more than 3,000 residents, hosted its ... the 6th of December. , Featuring Santa, Christmas lights ... Eufaula on Main Street. Narconon Arrowhead’s parade float ...
(Date:12/19/2014)... An evening dress is perfect for any occasion and is ... dresses retailer, has unveiled its new selection of evening dresses. ... shopping platform. Customers can view more at its ... been accepted and praised by customers for many years. It ... clients. In order to expand its market share, the company ...
(Date:12/19/2014)... print component of Vision and Hearing is distributed within ... with a circulation of approximately 230,433 copies and an ... nationally through a vast social media strategy and across ... To explore the digital version of the campaign, ... exclusive interview with Mark DeMontis , sharing his experience ...
(Date:12/19/2014)... intestinal bacteria that cause inflammatory bowel disease, which includes ... report. The findings, published recently in the journal ... prevent the disease and treat the 1.6 million Americans ... "The intestinal bacteria, or ,gut microbiome, you develop at ... on your health for the rest of your life," ...
(Date:12/19/2014)... (HealthDay News) -- Potentially illness-causing E. coli bacteria were ... markets, according to a new study. Researchers checked ... 13 farmers markets in Los Angeles and Orange counties ... almost 150 samples tested, 24 percent were positive for ... to the researchers. Both types of bacteria can ...
Breaking Medicine News(10 mins):Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Attractive Evening Dresses Announced by Discount-Dress.com 2Health News:Mark DeMontis, Founder of Courage Canada, shares his passion for bringing hockey to those affected by blindness in Mediaplanet’s “Vision and Hearing” campaign 2Health News:Crohn's, Colitis May Have Genetic Underpinnings, Study Finds 2Health News:E. Coli Germs Found on Farmers Market Herbs 2
... total of 2416 cases of SARS with 89 deaths from ... (3), Malaysia (1), and Singapore (1).,New cases that were reported ... (2), Singapore (1), the United Kingdom (1), and the United ... has developed an unusual pattern of transmission that is not ...
... A study of patients with viral encephalitis by ... the condition could cause seriouys movement,problems. The investigators ... five,of whom had West Nile virus. They found ... intensive care, while four developed severe movement disorders ...
... that those who suffer,from post-herpetic neuralgia or pain following ... patch of Capsaicin, the active ingredient of chili peppers.,Shingles ... chicken pox.,Shingles results in the occurrence of painful rashes ... persist even after the rashes have disappeared.// Researchers have,now ...
... researchers led by Annette Wind Olsen have reported in ... pregnancies that last,longer than 42 weeks or 294 days. ... mothers. The researchers conducted a study of about 28,000,women ... group had a first,pregnancy that had lasted longer than ...
... FDA has proposed two new rules that would help improve ... believed to be responsible for as many as 7,000 deaths. ... similar names, poor handwriting by doctors on prescriptions, or too ... from patient to patient. A 1999 study reported// between 45,000 ...
... the March issue of the journal Alcoholism: Clinical and ... sense of smell. Researchers from the University Clinics of ... and 30 healthy people who were matched for age, ... are pen-like devices that dispense odour, to test each ...
Cached Medicine News:
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: