Forest announced that Daliresp (roflumilast tablets) has been approved as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. This approval is based on data from eight randomized, double-blind, controlled, parallel-group trials involving 9,394 adult patients. Of the eight trials, two 1-year trials supported approval and enrolled patients with severe COPD associated with chronic bronchitis, at least one COPD exacerbation in the previous year, and at least a 20-pack/year smoking history. In both trials, Daliresp 500mcg once daily demonstrated a significant reduction in the rate of moderate or severe exacerbations compared with placebo. Daliresp reduced the rate of moderate or severe exacerbations by 15% in the first trial and by 18% in the second.
Daliresp is a selective phosphodiesterase type 4 (PDE4) inhibitor thought to exert its therapeutic effect via increased intracellular cyclic AMP in lung cells. Daliresp will be available in the second quarter of 2011.
For more information call (800) 678-1605 ext. 66297 or visit www.daliresp.com.