Forest Laboratories Inc. (NYSE: FRX) and Nycomed A/S said the US Food and Drug Administration (FDA) has approved Daliresp (roflumilast) oral tablet to treat chronic obstructive pulmonary disease (COPD).
In the US, roflumilast will be available in the second calendar quarter of 2011 and marketed exclusively by Forest Laboratories as Daliresp.
In August 2009, Forest Laboratories and Nycomed entered into a definitive collaboration and distribution agreement under which Forest acquired an exclusive license for Daliresp in the United States.
COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. 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, according to the FDA.
Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States.
Around 12 million people in the U.S. are currently diagnosed with COPD and an additional 12 million are likely to have the disease.
According to the FDA, roflumilast should not be used to treat sudden breathing problems, 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.
Roflumilast has been approved in the European Union and Canada in 2010 and it is marketed under the brand name Daxas. Daxas has been launched in several countries already, as for example Germany, Denmark, Sweden, UK, Canada and Spain. It is scheduled to be launched in other markets in 2011.