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news.Nycomed has announced encouraging results from a preliminary analysis of four Phase III trials of Daxas in the treatment of symptomatic chronic obstructive pulmonary disease.
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Two pivotal 12-month studies met their primary endpoints, showing effects on exacerbation rates and pulmonary function (FEV1). Furthermore, two supporting six-month studies confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Further analysis including the secondary endpoints is ongoing and full data from all four studies are expected to be published during 2009, the company said.
In light of the initial data analysis, Nycomed expects to file for European and US marketing authorization in 2009. The company will also initiate the process of identifying a partner to commercialize Daxas in the US.
Nycomed’s program for Daxas includes two international Phase III, 12-month trials, Hermes and Aura, which have recruited a total of 3,000 patients. The primary aim of both studies was to investigate the effect of Daxas on exacerbation rates and pulmonary function in severe and very severe chronic obstructive pulmonary disease (COPD) patients. Secondary endpoints included other lung function measurements and COPD symptoms as well as safety and tolerability. Daxas (500mcg roflumilast) was administered orally once daily for up to 52 weeks.
The randomized, double-blind, placebo-controlled studies were conducted in a number of territories, including the US, Europe, Canada, Australia, Russia, India and South Africa. Both Hermes and Aura met their primary endpoints. Further analysis, including of the secondary endpoints, is ongoing.
Two further Phase III studies, Eos and Helios, recruited more than 1,500 patients to evaluate the efficacy of Daxas when used concomitantly with standard bronchodilator treatments for COPD, that is, tiotropium or salmeterol. Both are multicenter, double-blind, randomized, parallel group studies in patients with moderate or severe COPD. The primary endpoints were a mean change in pre-bronchodilator FEV1 from baseline during the treatment period. Both Eos and Helios confirmed the efficacy of Daxas when used with standard bronchodilator treatments.