New partners Nycomed and Forest Laboratories have finally released the results from four pivotal late-stage studies of Daxas (roflumilast), an experimental treatment for chronic obstructive pulmonary disease. The developers say the trial data indicates that Daxas improves lung function and reduces exacerbations in patients when used in combination with long-acting bronchodilators.
The data, an analyses of which has been published in The Lancet, was gleaned from studies involving 4,500 patients. Switzerland developer Nycomed completed two year-long trials involving patients given daxas or a placebo and two other six-month long studies where patients were given Daxas or placebo in combination with a long-acting bronchodilator treatment (GlaxoSmithKline's Advair or Boehringer Ingelheim's Spiriva).
When used independently, Daxas reduced lung attacks requiring medical intervention by 17 percent per patient per year compared to placebo. The drug also increased the volume of air patients would breath out in one second. And when used in combination with a enhaled treatments, Daxas reduced exacerbations "over and above" what long-acting bronchodilators could do alone--which has industry-watchers buzzing that the drug will do well as an add-on treatment.
Nycomed and Forest filed for approval for Daxas in the U.S. and Europe earlier this year and hope to have the drug on the market in 2010. If approved, Daxas will be the first oral anti-inflammatory maintenance treatment for COPD. The drug will likely compete with Advair and Spiriva. Some industry analysts are skeptical, Reuters reports. Cowen analysts had expected the drug to reduce attacks by as much as 18 to 25 percent. The drug's road to development has been bumpy and an approval may not be in the bag just yet.
- here's the Nycomed release
- more from Reuters