FDA Approves Propellant-free Inhaler for COPD Patients

The Food and Drug Administration (FDA) has approved a new propellant-free inhaler for patients with chronic obstructive pulmonary disease (COPD).

The inhaler is from Boehringer Ingelheim Pharmaceuticals,Inc. and is to be marketed as Combivent Respimat in 2012. It is intended for patients with COPD who have continuous symptoms of bronchospasm and who require a second bronchodilator.

Previous studies including patients with COPD have found the combination of ipratropium bromide and albuterol sulfate gives patients significantly greater improvement in lung function than either component alone.

Currently, the only short-acting bronchodilator products providing both medications in a single inhaler are Combivent MDI and Combivent Respimat.

The inhaler was tested in a 12-week, randomized, double-blind, placebo and active-controlled clinical trial, during which Combivent Respimat was found to be clinically comparable to Combivent MDI, in terms of FEV1 (the maximal amount of air that can be forcefully exhaled in one second).

As Combivent Respimat is propellant-free, the inhaler utilizes a spring delivery mechanism which produces a slow-moving mist; it requires only one inhalation per dose, as opposed to Combivent MDI, which requires two. The new inhaler also has a dose indicator which displays how much of the medication is left in the inhaler.

"Combivent Respimat is a testament to our company's dedication and focus on making meaningful developments in respiratory medicine," reported Greg Behar, President and CEO, Boehringer Ingelheim Pharmaceuticals, Inc.

"Leveraging our extensive respiratory therapeutic experience and a long history of bringing innovative medicines to patients,” he added, “we continue to expand our strong clinical program examining the potential of several late-stage investigational compounds also delivered by the Respimat inhaler."

Combivent Respimat was developed as an answer to the Montreal Protocol, an international treaty which called for the phasing-out of inhalers using chlorofluorocarbons (CFS) as a propellant. This past month, the FDA announced the phasing out of the last over the counter inhaler utilizing CFS propellants.

Combivent Respimat will be available mid-2012; by January 1, 2014, Combivent Respimat will be the only Combivent product available, but Combivent MDI will be available until late 2013 to give patients adequate transition time.

"Boehringer Ingelheim invested more than 10 years developing Combivent Respimat," said Christopher Corsico, M.D., MPH, Senior Vice President, Medicine and Regulatory, Boehringer Ingelheim Pharmaceuticals, Inc. "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."