For Immediate Release: March 1, 2011
Inquiries: Morgan Liscinsky, 301-796-0397, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves new drug to treat chronic
obstructive pulmonary disease
Editor’s note: Daliresp has been approved as the trade
name for roflumilast.
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).
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.
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.
marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.