FDA Approves New Drug to Treat COPD

The U.S. Food and Drug Administration (FDA) has approved a new drug to treat chronic obstructive pulmonary disease (COPD), according to a statement released by the organization early last month. Roflumilast, which will go by the name Daliresp, is a new drug class for COPD treatment, which is typically administered through inhaled medications.

Administered in pill form, roflumilast inhibits the enzyme phosphodiesterase type 4 (PDE-4) and is taken to decrease the frequency of exacerbations or worsening of symptoms associated with COPD. It is indicated for people with severe COPD to treat the cough and excess mucus linked to bronchitis and is not for the treatment of the form of COPD that involves primary emphysema.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, in a press release distributed by the organization. “New treatment options that reduce frequency or 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.”

The safety and effectiveness of the new drug was tested in two Phase 3 clinical studies that included more than 1,500 patients age 40 and older with a history of chronic bronchitis that had experienced an exacerbation in the 12 months prior to the study.

The FDA notes that roflumilast should not be used to treat sudden breathing problems and is not recommended for people under the age of 18. The most common side effects include diarrhea, nausea, headache, insomnia, back pain, decreased appetite and dizziness.

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