Forest Laboratories has received approval from the US Food and Drug Administration (FDA) for Daliresp (roflumilast) as a treatment to reduce the risk of exacerbating chronic obstructive pulmonary disease.
Daliresp is indicated for patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of exacerbations.
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The once-daily oral tablet is the only selective phosphodiesterase-4 (PDE4) inhibitor that has been approved.
The efficacy and safety of Daliresp was assessed in eight clinical studies involving 9,394 adult patients.
FDA approval of Daliresp was based on results from two subsequent 1-year exacerbation trials.
In both trials, Daliresp 500mcg once-daily resulted in significant reduction in the rate of moderate or severe exacerbations compared to placebo.
Daliresp reduced the rate of moderate or severe exacerbations by 15% in one trial and by 18% in the other.
Forest expects Daliresp to be commercially available in the second calendar quarter of 2011.
Chronic obstructive pulmonary disease is a progressive, irreversible lung disease characterised by breathlessness, chronic cough and excessive production of phlegm. Approximately 12 million people in the US have been diagnosed with the disease.
