The US Food and Drug Administration has approved Roflumilast, a pill taken daily to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Roflumilast, a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD which involved primary emphysema.

The safety and effectiveness of Roflumilast was demonstrated in two Phase III clinical studies that included more than 1,500 patients ages 40 and older who received Roflumilast. 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 approved Roflumilast with 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. Roflumilast should not be used to treat sudden breathing problems (acute bronchospasm), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving Roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Source: US Food and Drug Administration