FDA green lights improved inhaler for Boehringer COPD drug
U.S. regulators have stamped an approval on a new inhaler that reduces the required inhalations per dose for Boehringer Ingelheim's treatment for chronic obstructive pulmonary disease (COPD), the company reports. The German drugmaker plans to bring the inhaler, the product of more than a decade of R&D, to the U.S. market in mid-2012.
The company lists multiple advantages of the new inhaler, which delivers the same two active ingredients, ipratropium bromide and albuterol sulfate, as its previously approved Combivent MDI product for COPD. The new inhaler--called Combivaent Respimat--doesn't require CFC propellants to bring the drugs into the lungs like its predecessor, according to the company. And the new version's spring mechanism delivers the treatment in one inhalation rather than two, which is the number required of the existing device.
Boehringer plans to continue to provide Combivent MDI through late 2013 as patients switch to the version of the product with the newly approved inhaler. A clinical study showed the Combivent MDI and Combivaent Respimat products were comparable in a measure of lung function used to keep score of the efficacy of COPD treatments.
"Boehringer Ingelheim invested more than 10 years developing Combivent Respimat," Dr. Christopher Corsico, senior vice president, medicine and regulatory, for Boehringer Ingelheim, said in a statement. "We are committed to ensuring patients and healthcare professionals are accurately instructed on how to use the new type of inhaler, before Combivent MDI is no longer on the market."
- here's the release