TUESDAY, March 1 (HealthDay News) -- Roflumilast has been approved by the U.S. Food and Drug Administration to treat flares of chronic obstructive pulmonary disease (COPD) involving chronic bronchitis.
In a news release, the agency said it didn't yet have a brand name for the just-approved drug, which is marketed 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.
More information
The U.S. National Heart Lung and Blood Institute has more about COPD.
