Novel COPD Therapy Daliresp Receives FDA Approval

The FDA has approved Daliresp to reduce the risk of COPD exacerbations in patients with severe COPD.

The FDA has approved Daliresp (roflumilast) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Daliresp is the first and only selective phosphodiesterase-4 inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

Forest Laboratories Inc. and its partner, Nycomed, expect Daliresp to be available to wholesalers in the second calendar quarter of 2011, according to a statement. “Nycomed is very pleased with the US approval of Daliresp by the FDA,” said Guido Oelkers, executive vice president of commercial operations at Nycomed. “With Forest we have an ideal partner, who is absolutely committed to make this innovative treatment available in the United States for the many patients suffering from severe COPD. The approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies.”

Last April, the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approving Daliresp, over concerns that the benefits did not outweigh the drug’s risks, according to

“COPD is a serious disease that gets worse over time,” Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

Norman Edelman, MD, chief medical officer at the 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 introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations,” said Stephen Rennard, MD, of the University of Nebraska Medical Center and clinical trial investigator. “Reducing the risk of COPD exacerbations is an important goal of COPD treatment.”

Roflumilast is not for use in treating sudden breathing difficulties. It comes with a medication guide alerting patients to potential mental health side effects including changes in mood, thinking or behavior. It can also result in unexplained weight loss. Common side effects of the drug include diarrhea, headache, nausea, dizziness, insomnia, back pain and a diminished appetite. It is not recommended for adolescents under 18 years of age. It has been available in Europe since last July.