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 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. 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:4/27/2016)... PARIS , April 27, 2016 ... Year-Over-Year Including 42% Growth in Recurring Consumable Sales  ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) ... today announced its sales for the first quarter ended ... business and the execution of its commercial strategy. ...
(Date:4/27/2016)...   Zillion Group today announced the ... which specializes in live video consultation. Turning content, ... Zillion enables companies to realize the true potential ... control of their health. Zillion,s ... one-to-one, group and webcast scheduled or on-demand – ...
(Date:4/27/2016)... LEXINGTON, Massachusetts , April 27, 2016 ... announces that Jeff Poulton , Chief Financial Officer, will ... in Boston, MA on Wednesday, May ... live audio webcast will be available on the Presentations and ... Subsequently, a replay of the webcast will be available on ...
Breaking Medicine Technology:
(Date:5/2/2016)... ... 2016 , ... Pregnancy Awareness Month offers a great time to get familiar ... you are ready to have a baby, it’s best to get started before age ... your Personal Conception & Pregnancy Organizer, written for women who plan on becoming pregnant ...
(Date:5/2/2016)... ... May 02, 2016 , ... TeleMedCo™, a ... designed to automate and improve the rapid diagnosis, triage and admission of patients ... platform, application, and mobile experience for the first time at GENBAND’s Perspectives16 conference. ...
(Date:5/2/2016)... ... May 02, 2016 , ... ... EVP and GM Jim Callandrillo and Duane Reed, VP of business development ... Pharmaceutical Business Intelligence and Research Group (PBIRG) General Meeting from May 15-17 ...
(Date:5/2/2016)... ... May 02, 2016 , ... Atlantic Information Services, Inc. (AIS) is pleased to ... Could Transform the Pharma Landscape .” CMS recently proposed a test of alternate payment ... drugs while preserving care provided to beneficiaries. The webinar will review the details of ...
(Date:5/2/2016)... ... 2016 , ... For many artists, the act of blending paint is based ... a science. , Using the new, highly precise METTLER TOLEDO ML204T balance to ... and meaning to his works. What’s more, it has allowed him to recreate these ...
Breaking Medicine News(10 mins):