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.
“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
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.