The drug, roflumilast -- carrying the trade name Daliresp -- will be sold in pill form, unlike some other medications for COPD, which are inhaled.
The FDA says roflumilast, a new drug class for COPD treatment, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4).
The pill is recommended for people with severe COPD associated with chronic bronchitis who have had flares. Roflumilast has been shown to reduce the risk of COPD flares in this group. It is not intended to treat another form of COPD, which involves primary emphysema.
The FDA approval of roflumilast requires 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.
“COPD is a serious disease that gets worse over time,” Curtis Rosebraugh, MD, MPH, of FDA, says in a news release.
“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,” says Rosebraugh, director of the office of drug evaluation in the FDA’s Center for Drug Evaluation and Research.
The FDA says in a news release that the safety and effectiveness of roflumilast was demonstrated in two phase III clinical trials that included more than 1,500 patients 40 and older.
The federal agency says that 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 says roflumilast should not be used to treat sudden breathing problems and is not recommended for people younger than 18.