Navigation Links
Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
Date:9/14/2009

ive findings. However, there is much value we can bring to patients through our Staccato technology, as evidenced by our late-stage, pre-NDA program with AZ-004 (Staccato loxapine, high dose) for the acute treatment of agitation."

AZ-104 Phase 2b Clinical Trial Design

The AZ-104 Phase 2b clinical trial was an outpatient, multi-center, randomized, double-blind, single administration, placebo-controlled study. The study was designed to evaluate the treatment of a single migraine attack of moderate to severe intensity in each of approximately 360 migraine patients, with or without aura. Two doses of AZ-104 (1.25 mg and 2.5 mg) and placebo were evaluated in the clinical trial. The study enrolled a total of 366 patients: 125 patients in the placebo dose group, 121 patients in the 1.25 mg dose group, and 120 patients in the 2.5 mg dose group.

Patients rated their headache pain using the International Headache Society (IHS) 4-point rating scale. The primary efficacy endpoint was headache pain relief (headache pain rated as mild or none) at 2 hours post-dose. Secondary efficacy endpoints for the clinical trial included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia. All results were considered statistically significant at the p < 0.05 level, as compared to placebo, and all analyses were made on an intent-to-treat basis. Safety evaluations were also made throughout the clinical trial period.

Primary Efficacy Endpoint

AZ-104 was numerically superior to placebo in pain-relief at 2-hours post-dose, but these differences were not statistically significant. Pain relief was observed in 56% of patients receiving the 2.5 mg dose (p=0.11) and 54% of patients receiving the 1.25 mg dose (p=0.12), as compared to 45% of patients receiving placebo.

Another commonly used measure of efficacy i
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
8. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
9. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
10. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... July 28, 2014  ANI Pharmaceuticals, Inc. (NASDAQ: ... to release its second quarter and year-to-date 2014 financial ... of the U.S. financial markets. The earnings press release ... the Company,s website, www.anipharmaceuticals.com . ... and Charlotte C. Arnold , Vice President and ...
(Date:7/28/2014)... 28, 2014  ProteinSimple announced today that it has ... new assay allows users to detect all proteins separated ... Western users can analyze proteins without the need for ... changed protein analysis as we know it today. First, the ... - no messy gels, no transfer tanks, no blots, ...
(Date:7/28/2014)... , July 28, 2014 ... £2.5 million to help it meet the global ... healthcare, pharmaceuticals and logistics. Albion joins Shackleton Ventures. ... Over the past 18 months OmPrompt ... platform, its management team and its operations. The ...
Breaking Medicine Technology:ANI Pharmaceuticals Schedules Conference Call for Second Quarter 2014 Financial Results 2ProteinSimple Says "Never Run a Gel Again!" 2OmPrompt Funded for Customer Automation Management Market Expansion 2
(Date:7/28/2014)... July 28, 2014 Humility of Mary Health ... 20 at St. Elizabeth Boardman Health Center, 8401 Market St., ... provides information about more than 200 common health problems as ... preventing illness and injury, and advice on when to seek ... a.m. to noon, the evening session runs from 5:30 to ...
(Date:7/28/2014)... 2014 For those with dust allergies, home ... dust allergies—commonly settle in mattresses, bedding, and upholstered furniture and ... mites are microscopic insects that feed on the dead skin ... to keep a million dust mites fat and happy. When ... microscope, the decaying bodies and feces of dust mites can ...
(Date:7/28/2014)... July 28, 2014 Scientists in Japan ... an improved blood test for the asbestos cancer mesothelioma. ... new research. Click here to read it now. ... at Tokyo’s Juntendo University Graduate School of Medicine say ... is a step above the old test. , ...
(Date:7/28/2014)... 2014 Maternal and Family Health Services ... which will be presented at the agency’s 43rd Annual ... at the Westmoreland Club in Wilkes-Barre. , The late ... long-time employee of MFHS. She dedicated her life ... health advocate, and champion for women, children and families ...
(Date:7/28/2014)... new study has found that following a healthy lifestyle ... metabolic syndrome. Published early online in CANCER , ... findings indicate that children with cancer and adults who ... about how their lifestyle may influence their long-term health. ... known to be at increased risk for the metabolic ...
Breaking Medicine News(10 mins):Health News:HMHP Offers ‘Health at Home’ Workshop 2Health News:AllergyEasy® Announces No-shots Immunotherapy to Mitigate Dust Allergies 2Health News:AllergyEasy® Announces No-shots Immunotherapy to Mitigate Dust Allergies 3Health News:Test Results Look Promising for New Mesothelioma Blood Test, According to Surviving Mesothelioma 2Health News:MFHS Seeking Nominations for Rose Allan Tucker Award 2Health News:Lifestyle choices may affect the long-term heart health of childhood cancer survivors 2
... Pa., Jan. 15 Today marked the launch ... http://www.nabita.org ). NaBITA,s mission: The National Behavioral ... education, development and support to professionals in schools ... to make their campuses and workplaces safer through ...
... 15 Eli Lilly and Company,(NYSE: ... resolution with the United,States Attorney for the Eastern ... Litigation of the Department of Justice regarding the,previously-reported ... promotional practices for the antipsychotic medication,Zyprexa(R) (olanzapine). , ...
... of the revolutionary MyFluVaccine program launches new website as it ... ... (Vocus) January 15, 2009 -- FFF Enterprises, the nation’s largest ... critical-care biopharmaceuticals announced today the unveiling of its new and ...
... Valley Hospital chooses IVANS LIME, impressed with quick turnaround time and ... ... 15, 2009 -- IVANS , the leading provider of corporate ... choosing high-speed Internet technology over dial-up to access Medicare as they ...
... January 15 Essilor,International announced today that its ... share purchase agreement whereby it has offered to ... of ophthalmic lenses. The,agreement is subject to certain ... Signet Armorlite,s main host,countries. The acquisition is expected ...
... great friend to The Brain Tumor Foundation lost his battle ... surrounded by his family.David fought his illness with courage and ... website, 38lemon.com , he shared his personal battle and ... cancer. So named because of his diagnosis of a ...
Cached Medicine News:Health News:Preventing the Next Virginia Tech -- The National Behavioral Intervention Team Association Launched Today 2Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 2Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 3Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 4Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 5Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 6Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 7Health News:FFF Enterprises Launches New MyFluVaccine Website 2Health News:FFF Enterprises Launches New MyFluVaccine Website 3Health News:Healthcare Providers Choosing IVANS High-Speed Technology to Succeed Within Medicare Modernization Era 2Health News:Healthcare Providers Choosing IVANS High-Speed Technology to Succeed Within Medicare Modernization Era 3Health News:Essilor Agrees to Acquire Signet Armorlite 2
To enter, dissect, elevate and smooth the flap. Combined features of Spatula, Dissector and Forceps. - Also available in Titanium...
Khosla Precision and Quality in Medical and Surgical Products....
The Retina 145 L direct contact glass is a panfundus wide-angle viewing device designed to facilitate the problem-free diagnosis and treatment of the retina as far as the equator....
For children up to 4 years of age 11 mm internal diameter of the cornea part. Designed to work with argon/YAG Lasers....
Medicine Products: