Nycomed and Forest Laboratories have announced results of four phase III trials published in The Lancet. Result showed that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Roflumilast, a once-a-day oral tablet, would be the first in treatment of COPD if it receives regulatory approval from the EMEA and the FDA. The phase III placebo-controlled trials of roflumilast evaluated the treatment in two 12-month and two six-month studies, involving 4,500 patients in ten countries.
The two 12-month studies demonstrated that roflumilast produced a statistically significant and clinically relevant reduction in exacerbations, even for patients who were also taking long-acting bronchodilators. The studies showed a reduction in moderate-to-severe exacerbations by 17% per patient per year. The reduction in exacerbations was irrespective of concomitant treatment with long-acting beta-2 agonists, a standard bronchodilator therapy. When added to standard bronchodilator therapies in the two six-month studies, a clear trend for the reduction of exacerbations was observed with roflumilast, over and above what was achieved with these therapies alone.
Peter Calverley, professor of Respiratory Medicine, University of Liverpool and the lead author, said: COPD can devastate people’s lives and exacerbations can be extremely frightening, so a novel tablet like roflumilast is really exciting for those of us treating patients. Roflumilast acts differently to bronchodilators as it acts on the underlying condition, not primarily impacting on everyday symptoms. It acts slowly and the effects, as we saw in our studies, are gradual and sustained.