Daliresp Approved for Form of COPD
TUESDAY, March 1 -- Daliresp (roflumilast) has been approved by the U.S. Food and Drug Administration to treat flares of chronic obstructive pulmonary disease (COPD) involving chronic bronchitis.
The lung disease leads to labored breathing, and is characterized by chronic cough and excessive phlegm. A flare may last for weeks and puts patients at increased risk of death, the FDA said. Cigarette smoking is the leading cause of COPD.
Roflumilast is marketed as Daliresp by St. Louis-based Forest Pharmaceuticals.
Roflumilast blocks an enzyme called phosphodiesterase type 4. The drug is not intended to treat another form of COPD, primary emphysema, the FDA said.
The medication's safety and effectiveness were evaluated in clinical studies involving more than 1,500 people, 40 and older, who had a worsening of chronic bronchitis during the prior year. Roflumilast was approved with a guide that informs users of potential serious side effects, including changes in mood, thinking or behavior, and unexpected weight loss, the agency said.
The most common adverse reactions were diarrhea, nausea, headache, insomnia, back pain, loss of appetite and dizziness. Roflumilast shouldn't be used to treat sudden breathing problems, and isn't recommended for people younger than 18.
The U.S. National Heart Lung and Blood Institute has more about COPD.
Posted: March 2011