FDA Approves New Drug to Treat COPD
Daliresp Will Be Sold in Pill Form to Treat Chronic Obstructive Pulmonary Disease
By Bill Hendrick
WebMD Health News
Reviewed by Laura J. Martin, MD
graphic of lung

March 1, 2011 -- The FDA has approved a new treatment for people with worsening symptoms of severe chronic obstructive pulmonary disease (COPD), a lung disorder that makes breathing difficult.

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 to treat symptoms of cough and excess mucus linked to bronchitis. It is not intended to treat another form of COPD, which involves primary emphysema.

The FDA’s approval was announced even though the agency’s advisory panel voted 10-5 on April 7, 2010, not to recommend approval of the once-daily pill.  At the time the panel members decided the drug had too many adverse effects to offset what the FDA called a “modest” increase in lung function attributable to roflumilast.

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.

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COPD Symptoms

Symptoms of COPD include breathlessness, chronic cough, and excessive phlegm.

An exacerbation can last up to several weeks and result in a decline in lung function and increased risk of death, and it may be associated with severe anxiety, the FDA says.

Cigarette smoking is the leading cause of COPD.

“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.
Side Effects

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.

The most common side effects include diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

The medication is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.