FDA Approves New Drug to Treat COPD

March 04, 2011

WASHINGTON DC- March 4, 2011- The U.S. Food and Drug Administration has approved roflumilast, a pill taken daily to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

“The COPD Foundation congratulates Forest Laboratories for the approval of roflumilast as an indication to treat COPD-related bronchitis,” says John W. Walsh, President and Co-Founder of the COPD Foundation. “We’re excited that this the first in a new drug class for the treatment of COPD and that it addresses the critical importance of reducing exacerbations.”

Daliresp (which has been approved as the trade name for roflumilast) is the first selective phosphodiesterase type 4 (PDE-4) inhibitor to be approved in the U.S. One year clinical studies show Daliresp significantly reduced the rate of exacerbations versus placebo, according to Forest Laboratories. 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. 

“Only a small number of medications have been FDA approved for use in COPD,” says Dr. Byron Thomashow, Chair of the COPD Foundation Board of Directors. “It is the first in a new class of medications approved for COPD in many years. COPD is almost always preventable and almost always treatable. We now have another excellent medication to add to our therapeutic choices.”

About the COPD Foundation
The COPD Foundation is dedicated to developing and supporting programs, which improve the quality of life through research, education, early diagnosis, and enhanced therapy for persons whose lives are impacted by Chronic Obstructive Pulmonary Disease (COPD). The COPD Foundation has several programs dedicated to informing, empowering, educating, and engaging individuals affected by COPD, including both diagnosed and undiagnosed individuals, their families and friends, and their medical professionals.

About COPD
COPD is the third leading cause of death in the U.S. and the only chronic disease growing in mortality. It affects approximately 24 million Americans but only 12 million are diagnosed. COPD includes chronic bronchitis, emphysema, and adult onset (refractory) asthma. Symptoms include breathlessness, wheezing, and chronic coughing. Visit our website or call 1-866-316-COPD (2673).