Navigation Links
MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate

Lower systemic drug exposure observed compared to currently marketed

conventional nebulized budesonide

MOUNTAIN VIEW, Calif., March 24 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today that in a pharmacokinetic clinical trial Unit Dose Budesonide (UDB) demonstrated lower systemic drug exposure when compared to the currently marketed conventional nebulized budesonide. UDB is MAP Pharmaceuticals' proprietary nebulized formulation of budesonide, currently in Phase 3 clinical development, for the potential treatment of pediatric asthma. UDB is designed to be administered more quickly and to provide efficacy at lower doses than conventional nebulized budesonide, which is the current leading treatment for pediatric asthma.

The clinical trial was a randomized, open label, cross-over study evaluating the pharmacokinetic profile of two doses of UDB given twice daily in 32 adults with mild to moderate asthma. A 0.135 mg dose of UDB was compared as an alternative to a 0.25 mg dose of conventional nebulized budesonide given twice daily, and a 0.25 mg dose of UDB was compared as an alternative to a 0.5 mg dose of conventional nebulized budesonide given twice daily.

In this study UDB demonstrated faster times to maximum blood concentrations as compared to conventional nebulized budesonide, and had similar maximum blood concentrations. No serious adverse events were reported in the study and nebulization time for UDB in this adult population was shorter than for the currently marketed conventional nebulized budesonide product.

"We are pleased to confirm that the UDB doses we are evaluating as part of our Phase 3 clinical program resulted in lower systemic drug exposure compared to the currently marketed conventional nebulized budesonide," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "These results are consistent with our previous clinical studies, and we believe provide additional support for the safety of our next generation pediatric asthma therapy."

The company plans to present the results from this study at a future scientific conference.

About Unit Dose Budesonide

MAP Pharmaceuticals is developing Unit Dose Budesonide, a novel version of nebulized budesonide for treating pediatric asthma in children from 12 months to eight years of age. Budesonide is an inhaled corticosteroid that has been used for more than 20 years with demonstrated safety and efficacy. It is the only corticosteroid approved for treating asthma in pregnant women and in children as young as 12 months old. UDB is designed to be administered more quickly and to provide efficacy at a lower corticosteroid label dose than the commercially available product.

About Pediatric Asthma

Of the estimated 20 million diagnosed asthma patients in the United States, approximately 6.8 million are children under 18 years of age and approximately 1.2 million are children under five years of age. Guidelines released in 2007 recommend the prophylactic use of inhaled corticosteroids (ICS) as the preferred initial treatment to reduce inflammation and maintain long-term control of asthma in children of all ages.

In the United States, children under the age of five typically use a nebulizer to receive inhaled corticosteroid medication because they lack the breath coordination needed to use pressurized metered-dose inhalers or they lack the lung capacity needed to use dry powder inhalers. The current goal of asthma management is, with proper treatment, to allow children with asthma to lead active lives.

Since the introduction of conventional nebulized budesonide, annual sales have grown to approximately $700 million in the United States and approximately $900 million worldwide in 2006, according to data published by IMS Health.

About MAP Pharmaceuticals, Inc.

MAP Pharmaceuticals develops and plans to commercialize new therapies for children and adults who suffer from chronic conditions that it believes are not adequately treated by currently available medicines. The company applies its proprietary inhalation technologies to enhance the therapeutic benefits and commercial attractiveness of proven drugs while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. MAP Pharmaceuticals has two drug candidates, Unit Dose Budesonide and MAP0004, in late stage development for the potential treatment of pediatric asthma and migraine respectively. MAP Pharmaceuticals' pipeline also includes a drug candidate in early clinical development for the treatment of asthma and chronic obstructive pulmonary disease.

Additional information about MAP Pharmaceuticals can be found at

SOURCE MAP Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
(Date:6/23/2016)... -- Guerbet announced today that it has been named a ... One of 12 suppliers to receive the ... of Premier members through exceptional local customer service and ... lower costs. "We ... customer service from Premier," says Massimo Carrara , ...
(Date:6/23/2016)... , June 23, 2016 ... "Surgical Procedure Volumes: Global Analysis (United States, China, ... Canada)" report to their offering. ... essential tool for healthcare business planners, provides surgical procedure ... at surgery trends with an in-depth analysis of growth ...
(Date:6/23/2016)... NEW YORK , June 23, 2016 ... rough waters, but it continues to present great opportunities ... featured companies for today: Intrexon Corp. (NYSE: ... ), Arena Pharmaceuticals Inc. (NASDAQ: ARNA ), ... Learn more about these stocks and receive your complimentary ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center for ... Table in Battle Creek, MI, where the rehabilitation facility is located. This annual celebration ... world’s leading providers of cereal and other breakfast foods. Its residents often refer to ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
Breaking Medicine News(10 mins):