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MAP Pharmaceuticals Initiates Phase 3 Clinical Trial Of Unit Dose Budesonide In Children With Asthma
MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP), an emerging pharmaceutical company,
announced it has initiated a Phase 3 clinical trial evaluating Unit
Dose Budesonide (UDB), the company's proprietary nebulized version of
budesonide, for the potential treatment of pediatric asthma.
UDB is an inhaled corticosteroid that is designed to be administered
more quickly and to provide efficacy at lower doses than conventional
nebulized budesonide and thus may offer improved safety, convenience and
compliance for young patients who suffer from asthma.
The Phase 3 clinical trial is a multi-center, randomized, double-blind,
placebo controlled study in approximately 360 asthmatic children, 12 months
to eight years of age. Patients are randomized to either 0.25mg UDB,
0.135mg UDB or placebo given twice a day over a 12-week treatment period.
The primary efficacy endpoint for the study is the change in nighttime and
daytime composite symptom scores (cough, wheeze and breathlessness).
"Unit Dose Budesonide is one of MAP Pharmaceuticals' two most advanced
product candidates, and we are excited to announce the initiation of this
Phase 3 clinical trial," said Timothy S. Nelson, President and Chief
Executive Officer of MAP Pharmaceuticals. "We look forward to working with
our investigators to continue to study the safety and efficacy of UDB and
to support our goal of developing a convenient low dose therapy for the
treatment of asthma in young children."
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 6.5 million are children under 18 years of age and
approximately 1.4 million are children under five years of age. Guidelines
released in 2007 recommend the prophylactic use of inhaled corticosteroids
(ICS) as the preferred treatment to reduce inflammation and maintain
long-term control of asthma in children aged five years and younger.
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 diseases that the company believes
are not treated adequately by currently available medicines. The company
uses 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. The company has several proprietary product candidates in clinical
development that address large market opportunities, including its two most
advanced product candidates: a proprietary version of nebulized budesonide
for the potential treatment of children with asthma (UDB), and a
proprietary version of orally inhaled dihydroergotamine delivered by MAP
Pharmaceuticals' proprietary Tempo(TM) inhaler for the potential treatment
of migraine (MAP0004). In addition to UDB and MAP0004, MAP Pharmaceuticals
has several other proprietary product candidates in clinical development
that also address large market opportunities, including a proprietary
combination of an inhaled corticosteroid and a long-acting beta2-agonist
for the potential treatment of asthma and chronic obstructive pulmonary
disease.
Additional information about MAP Pharmaceuticals can be found at
http://www.mappharma.com.
Forward-Looking Statements
In addition to statements of historical facts or statements of current
conditions, this press release contains forward-looking statements,
including with respect to the development, therapeutic potential and safety
of the company's UDB product candidate. Actual results may differ
materially from current expectations based on risks and uncertainties
affecting the company's business, including, without limitation, risks and
uncertainties relating to the enrollment and conduct of clinical trials, as
well as risks relating to failure to achieve favorable clinical outcomes
and that UDB will not be approved for commercial use by the United States
Food and Drug Administration. The reader is cautioned not to unduly rely on
the forward-looking statements contained in this press release. MAP
Pharmaceuticals expressly disclaims any intent or obligation to update
these forward-looking statements, except as required by law. Additional
information on potential factors that could affect MAP Pharmaceuticals'
results and other risks and uncertainties are detailed in its Quarterly
Report on Form 10-Q, filed with the SEC on November 19, 2007, and available
at http://edgar.sec.gov.
MAP Pharmaceuticals, Inc.
http://www.mappharma.com
HARTA Pharmaceuticals iniþiazã Faza 3 studiu clinic de unitate Budesonide Doza la copiii cu astm bronºic - MAP Pharmaceuticals Initiates Phase 3 Clinical Trial Of Unit Dose Budesonide In Children With Asthma - articole medicale engleza - startsanatate