Nycomed says that four late-stage studies demonstrate that its investigational chronic obstructive pulmonary disease drug Daxas improves lung function, reduces exacerbations and shows promise as an add-on treatment to long-acting inhaled drugs.

Data from the studies, to be published in The Lancet revealed that in two 12-month trials, the once-a-day oral tablet Daxas (roflumilast) reduced moderate or severe exacerbations by 17% per patient per year compared with placebo. Also, two six-month studies showed that when added to standard bronchodilator therapies, ie GlaxoSmithKline’s Advair (salmeterol) and Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium), “a clear trend for the reduction of exacerbations” was observed with Daxas, “over and above what was achieved with these therapies alone”, Nycomed said.

Peter Calverley of the University of Liverpool, and lead author of the 12-month studies, noted that “exacerbations can be extremely frightening, so a novel tablet like roflumilast is really exciting”. Daxas is a phosphodiesterase 4 enzyme inhibitor, which works 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,” he added.

Leonardo Fabbri, of the University of Modena and Reggio Emilia, Italy, and lead author of the six-month trials, said that Daxas has the potential to be “the only completely new treatment option for COPD in the next several years”. He added that the additive effect of roflumilast on top of Advair and Spirivia “support and extend the findings of the 12-month trials, by showing a clinically relevant lung function improvement in patients with impaired lung function on top of maximum bronchodilation”.

Nycomed’s R&D chief, Anders Ullman, said that in the four studies Daxas showed “clear therapeutic potential, decreasing exacerbations and improving lung function”. He added that “the uniformity of the results is really encouraging and gives us great hope that our faith in roflumilast has been confirmed”.

Nycomed has already submitted Daxas to European and US regulators for approval and has high hopes that the treatment will be a blockbuster. Analysts seem to agree and believe that the drug’s principal potential lies as an add-on.

Earlier this month, Forest Laboratories signed up to be the US licensee for Daxas.