The treatment: A new anti-inflammatory drug
New Treatments for COPD: Page 6
What's new: Roflumilast
In June of 2010, a new medication, roflumilast (brand name Daxas) was approved in Europe for COPD. Doctors and patients are excited because it's the first time in ten years that a medication with a new type of action has been approved to treat COPD. Daxas works by counteracting the effect of an enzyme that contributes to inflammation -- so it targets the underlying inflammatory mechanism of COPD rather than the symptoms of inflammation.
Clinical trials showed roflumilast to be effective but to have side effects, such as nausea, diarrhea, and headache. Because of these side effects, the FDA refused to approve Daxas in the U.S., and patient advocates say the approval process is stalled.
Why it's encouraging: In Canada, Daxas is well on its way to approval. The four major clinical trials of Daxas included Canadian populations, and the research centers studying the drug at McMaster and other Canadian universities are enthusiastic. Nycomed, which makes the drug, is working with Merck to ramp up major production and promotion of Daxas in both Europe and Canada; insiders expect Canadian approval this winter. That might spur the FDA to speed up the approval process here in the U.S.
What to watch for: While it may be tempting to import Daxas from Canada, and Canadian drug sites are already listing it, this is a risky thing to do as there have been numerous reports of counterfeit drugs passed off as the real thing.