Navigation Links
UPDATE: FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
Date:3/1/2011

SILVER SPRING, Md., March 1, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)  

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough, and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States.

Roflumilast, a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD which involves primary emphysema.

"COPD is a serious disease that gets worse over time," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease."

The safety and effectiveness of roflumilast was demonstrated in two Phase 3 clinical studies that included more than 1,500 patients ages 40 and older who received roflumilast. Those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to be
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. UPDATE: Nile Therapeutics Announces Positive Phase 1a Results of CD-NP, a Selective NPR-B Agonist in Clinical Development for the Treatment of Heart Failure
2. UPDATE: New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
3. UPDATE: Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension
4. UPDATE: Infant Primates Given Vaccines on U.S. Childrens Immunization Schedule Develop Behavioral Symptoms of Autism
5. ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
6. UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPars Investigational Cancer Drug BSI-201
7. UPDATE: FDA Issues 22 Warning Letters to Web site Operators
8. Update: International HIV/AIDS Partnership Wins Two Awards for Supply Chain Excellence
9. UPDATE: China PharmaHub Corp. Introduces a Magic Bullet Liver Cancer Therapy to China, Hong Kong, Taiwan, Macau, Singapore, Malaysia, and Bangladesh
10. Update: Clinical Trial Establishes Catheter-based Aortic Valve Replacement As New Standard of Care for Patients Who Cannot Undergo Surgery
11. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... -- For its innovative modular Biomedical Research building in ... has earned a Modular Building Institute (MBI) 2014 Award ... categories, MBI,s contest is the commercial modular industry,s premier ... dealers, and product and service providers. ... our team," said Dan Palmer , President of ...
(Date:7/31/2014)... NEW YORK and VIENNA , ... today at a press conference in New York ... of PD01A, a vaccine against Parkinson,s disease. PD01A is the ... target, to enter clinical testing. The Michael J. ... a $ 1.5 million grant, and presented at the press ...
(Date:7/31/2014)... Ariz. , July 31, 2014 For ... public can watch the implantation of the SynCardia temporary ... paper and matching video posted on the Journal of ... video and read the paper on the SynCardia Total ... The 16-minute video accompanies "Implantation of the SynCardia Total ...
Breaking Medicine Technology:Art's Way Scientific Earns Prestigious Modular Building Institute Award 2Art's Way Scientific Earns Prestigious Modular Building Institute Award 3Art's Way Scientific Earns Prestigious Modular Building Institute Award 4First Clinical Data of Therapeutic Parkinson's Disease Vaccine Encourages Continued Development 2First Clinical Data of Therapeutic Parkinson's Disease Vaccine Encourages Continued Development 3First Clinical Data of Therapeutic Parkinson's Disease Vaccine Encourages Continued Development 4How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 2How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 3
... N.Y., Oct. 20, 2011 Misonix, Inc. (NASDAQ: ... manufactures and markets innovative therapeutic ultrasonic products worldwide for ... surgical and medical applications, today announced that it has ... Mystaire, Inc. for $1.5 million in cash plus a ...
... Calif., Oct. 20, 2011 WaferGen Biosystems, Inc. ... organizational changes to strengthen domain leadership and enhance ... its SmartChip System.   As an ... formerly President and a director of Helicos BioSciences ...
Cached Medicine Technology:Misonix Announces the Sale of Its Laboratory and Forensic Safety Products Business for $1.5 Million 2WaferGen Announces Organizational Changes to Enhance Commercialization of SmartChip System 2WaferGen Announces Organizational Changes to Enhance Commercialization of SmartChip System 3
(Date:7/31/2014)... 2014 On October 10, at ... the Mesothelioma Applied Research Foundation, in collaboration with ... one-day regional mesothelioma conference geared to ... topics related to mesothelioma and presented by local ... topics will include imaging, genetics, first-line therapies, surgery, ...
(Date:7/31/2014)... August 01, 2014 The 2013 ... increasing 0.89 points from 75.07 in 2012. The ... tourism-related sectors and integrates them into an overall ... become increasingly more satisfied with Hong Kong over ... consistently excelling in service performance in Hong Kong ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 Hoping to attract ... they can trust , NutriGold is ready to ship ... up to make taking advantage of this offer fast and ... of Research and Development at NutriGold, "We know that every ... us with their most precious asset: their own health or ...
(Date:7/31/2014)... 31, 2014 United Theological Seminary will ... on Monday, September 15, with its 2014 Opening Convocation, ... 3440 Shroyer Rd., Kettering, OH. Dr. Emma J. Justes, ... Emma Toussant Chair will speak on “Unexpected Undercurrents: Responding ... teaching and research interests include pastoral care and counseling, ...
(Date:7/31/2014)... 2014 0-6 Pack Abs has finally been ... therapist expert Dr. James Vegher. Together they have launched ... relieve digestive issues, tone core muscles, improve posture, eliminate achy ... core exercises used to re-train the body in order to ... 0-6 Pack Abs review, Shane Michaels, a fitness ...
Breaking Medicine News(10 mins):Health News:October Events: Regional Conference on Mesothelioma in Chicago 2Health News:October Events: Regional Conference on Mesothelioma in Chicago 3Health News:PolyU Released Report On 2013 Tourist Satisfaction and Tourism Service Quality Indices to Boost Tourism Development 2Health News:PolyU Released Report On 2013 Tourist Satisfaction and Tourism Service Quality Indices to Boost Tourism Development 3Health News:NutriGold Launches Product Samples Page for its Supplements 2Health News:NutriGold Launches Product Samples Page for its Supplements 3Health News:United Theological Seminary to Open 144th Year 2Health News:Zero To Six Pack Abs System Review Exposes Tyler Bramlett And Dr. James Veghers’ New Ab Training Program 2Health News:Zero To Six Pack Abs System Review Exposes Tyler Bramlett And Dr. James Veghers’ New Ab Training Program 3
... ... ... After a long and, for many Americans, extraordinarily cold and snowy winter, springtime is finally ... to improve the quality of their sleep should see spring as a perfect occasion to ...
... prevented need for surgery in one group, and thwarted ... News) -- Researchers have succeeded in freezing away breast ... opening a promising door to a new generation of ... presented Tuesday at the Society of Interventional Radiology,s annual ...
... 16 Palladian Health , LLC, Chief Scientific ... Palladian,s Clinical Advisory Board, including Chairperson, Scott Haldeman , ... along with William Quillen , PT, PhD, FACSM, Director ... the University of South Florida , were prominent participants ...
... -survey conducted for Bioniche Food Safety-, , ... , , ... ... BELLEVILLE, ON , March 16 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, ...
... ... ... of Holistic Medicine has re-launched its website thanks to the growth of public interest in ... main presence on the Internet, and school officials are confident that the site will help ...
... ... ... dietary changes should be the principle foundation for combating U.S. childhood obesity, decades of ... cookie a day really mean anything to overall health? A recent New York Times ...
Cached Medicine News:Health News:Five Spring Cleaning Sleep Tips from SleepBetter.org 2Health News:Five Spring Cleaning Sleep Tips from SleepBetter.org 3Health News:Freezing Tumors Shows Promise Against Prostate, Breast Cancer 2Health News:Freezing Tumors Shows Promise Against Prostate, Breast Cancer 3Health News:Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery' 2Health News:Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery' 3Health News:Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery' 4Health News:Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery' 5Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 2Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 3Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 4Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 5Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 6Health News:Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms 7Health News:PCU College of Holistic Medicine Launches New Website 2Health News:Small Nutritional Changes are a Key to Health, Weight Loss, says DSM Personalized Nutrition 2Health News:Small Nutritional Changes are a Key to Health, Weight Loss, says DSM Personalized Nutrition 3Health News:Small Nutritional Changes are a Key to Health, Weight Loss, says DSM Personalized Nutrition 4
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... 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 ...
Medicine Products: