Nycomed to launch new study of Daxas benefits

Nycomed is to commence a new clinical study evaluating the benefits its chronic obstructive pulmonary disease (COPD) drug Daxas can offer to patients already undergoing standard fixed combination treatments and triple therapies.

The international phase III/IV trial will compare the effect of the drug to placebo among subjects who are being concomitantly treated with fixed-combination long-acting beta-2 agonists and inhaled corticosteroids, either with or without a long-acting muscarinic antagonist.

Conducted over 52 weeks, the study – named React – aims to demonstrate that Daxas can help to reduce the number of moderate and severe COPD exacerbations experienced by patients.

Enrolment for the trial is set to commence in the second quarter of 2011, with participants to be drawn from the population of patients with severe COPD associated with chronic bronchitis and frequent exacerbations.

Anders Ullman, executive vice-president for research and development at Nycomed, said: "We are confident that the React trial will provide further insights into how Daxas can be used most effectively and therefore help COPD patients receive the treatment they need."

Earlier this week, the company submitted an application to the European Medicines Agency for approval of its new short bowel syndrome treatment Revestive.