Anti-Inflammatory Approved for COPD

The Food and Drug Administration has approved roflumilast (Daliresp), a pill taken daily to decrease the frequency of flare-ups or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). Daliresp, the first in a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. It is not intended to treat emphysema.

The safety and effectiveness of Daliresp were demonstrated in two Phase 3 clinical studies that included more than 1,500 patients ages 40 and older who received the medication. 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 most common side effects reported by those receiving Daliresp included

  • diarrhea,
  • nausea,
  • headache,
  • insomnia,
  • back pain,
  • decreased appetite and
  • dizziness.

Other potential side effects include changes in mood, thinking or behavior, and unexplained weight loss.

Daliresp should be considered when first-line therapies are not tolerated or are not providing adequate benefit.

Source: Food and Drug Administration, March 1, 2011

Publication Review By: Peter B. Terry, M.D., M.A.

Published: 14 Aug 2013

Last Modified: 14 Aug 2013