Navigation Links
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 beginning treatment.

The FDA approved roflumilast with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.

Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.  

Roflumilast is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

For more information:

National Heart, Lung, and Blood Institute: Chronic Obstructive Pulmonary Disease

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




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

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... markets and sells medical devices and wearable sleep respiratory ... strategic cooperation agreement with Hongyuan Supply Chain Management Co., ... June 20, 2016, to develop Dehaier,s new Internet medical ... Dehaier will leverage Hongyuan Supply Chain,s sales platform to ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):