Pharmaceutical Business review

Nycomed plans to intiate COPD drug Phase III/IV study

Daxas (roflumilast) is an orally administered selective phosphodiesterase 4 (PDE4) enzyme inhibitor, which has been shown to inhibit COPD related inflammation with a novel mode of action.

The REACT study, a 52-week, randomised, double-blind, multi-centre study which will recruit approximately 2,000 patients from 21 countries, is the first to investigate Daxas when used in patients concomitantly treated with fixed combination treatment or triple therapy.

The trial will recruit patients with severe COPD associated with chronic bronchitis and frequent exacerbations, reflecting the licence indication for Daxas.

First patient enrolment is anticipated in second quarter 2011.