New drug approved for COPD by the FDA

By Dr. Ananya Mandal, MDMar 1 2011

The U.S. FDA has approved a new treatment for people with worsening symptoms of severe chronic obstructive pulmonary disease (COPD). COPD affects smokers and the elderly and leads to severe difficulty in breathing, chronic cough and excessive mucus production. 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.

The new drug roflumilast with a brand name Daliresp, will be sold in pill form, unlike some other medications for COPD, which are inhaled. Roflumilast is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4) which is believed to play a role in the inflammatory process involved with airway constriction. It falls into a new category of drugs known as PDE-4 inhibitors. It will be useful in 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 medication is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

The approval was announced even though the agency’s advisory panel - Pulmonary-Allergy Drugs Advisory Committee, voted 10-5 on April 7, 2010, not to recommend approval of the once-daily pill.  The panel members agreed upon the fact that the drug had too many adverse effects to offset what the FDA called a “modest” increase in lung function attributable to roflumilast. The approval is allowed on condition that patients are provided with details about the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.

The adverse effects as well as efficacy of the drug have been studied in two phase III clinical trials that included more than 1,500 patients 40 and older. The most common side effects include diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Dr. Curtis Rosebraugh director of the office of drug evaluation in the FDA’s Center for Drug Evaluation and Research said, “COPD is a serious disease that gets worse over time…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.”

Dr. Norman Edelman, chief medical officer, American Lung Association said that even with treatment the disease kills about 150,000 people each year. “We have some medications. We are able to treat COPD but they are not dramatic, they afford some relief. This new medication reduced exacerbation by about 15% so it’s not a miraculous new cure, but it’s certainly a welcome addition in the armamentarium of medications we use to treat this disease.”

The FDA says roflumilast should not be used to treat sudden breathing problems and is not recommended for people younger than 18. It has been approved in Europe – sold under the name Daxas – since last July.