Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.

COMBIVENT RESPIMAT and COMBIVENT MDI are indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

In a 12-week, randomized, double-blind, placebo and active-controlled clinical trial, COMBIVENT RESPIMAT was shown to be clinically comparable to COMBIVENT MDI, in terms of FEV1. FEV1 is the maximal amount of air that can be forcefully exhaled in one second. In the study, treatment was administered to patients with COPD four times a day.

COMBIVENT MDI and COMBIVENT RESPIMAT are the only short-acting bronchodilator products that offer two different medicines in a single inhaler. Clinical studies in patients with COPD have shown that the combination of ipratropium bromide and albuterol sulfate provides patients significantly greater improvement in lung function than either component alone.

COMBIVENT RESPIMAT uses a new type of inhaler with a propellant-free delivery mechanism to produce an slow-moving mist. COMBIVENT RESPIMAT requires one inhalation per dose as compared to COMBIVENT MDI, which requires two inhalations per dose. COMBIVENT RESPIMAT also offers a dose indicator to inform patients of the amount of remaining medication in the inhaler.

"COMBIVENT RESPIMAT is a testament to our company's dedication and focus on making meaningful developments in respiratory medicine," said 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, 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 in response to the Montreal Protocol, an international treaty requiring the phase-out of inhalers that use chlorofluorocarbons (CFCs) as propellants, such as COMBIVENT MDI. COMBIVENT RESPIMAT uses a spring mechanism to release the medication, rather than a propellant, so it does not release CFCs or hydrofluoroalkane (HFA) propellants.

COMBIVENT RESPIMAT will be available to patients by prescription starting in mid-2012. To allow adequate time to transition, COMBIVENT MDI will be available until late 2013. As of January 1, 2014, COMBIVENT RESPIMAT will be the only COMBIVENT product available.

"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."