FDA approves Boehringer Ingelheim’s Combivent inhalation spray for the treatment of COPD

This propellant-free inhaler product uses a slow-moving mist to deliver the same active ingredients of Combivent Inhalation Aerosol in a metered dose inhaler, but with only one inhalation per dose

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Written byJeffrey Bouley

RIDGEFIELD, Conn.—Boehringer IngelheimPharmaceuticals Inc. announced early this month that the U.S. Food and DrugAdministration (FDA) had granted approval for Combivent Respimat, a newpropellant-free inhaler product that uses a slow-moving mist to deliver thesame active ingredients of Combivent Inhalation Aerosol in a metered doseinhaler (also known as Combivent MDI).

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Jeffrey Bouley
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Both Combivent Respimat and Combivent MDI areindicated for use in patients with chronic obstructive pulmonary disease (COPD)on a regular aerosol bronchodilator who continue to have evidence ofbronchospasm and who require a second bronchodilator. They are reportedly theonly short-acting bronchodilator products that offer two different medicines ina single inhaler.

Where the Respimat product differs markedly fromthe MDI product is that the newly approved Combivent uses a new type of inhalerwith a propellant-free delivery mechanism to produce an slow-moving mist. Becauseof this, Combivent Respimat requires one inhalation per dose as compared to CombiventMDI, which requires two inhalations per dose. In addition, Combivent Respimat featuresa dose indicator to inform patients of the amount of remaining medication inthe inhaler.

Also notable is that Combivent Respimat wasdeveloped in response to the Montreal Protocol, an international treaty callingfor the phase-out of inhalers that use chlorofluorocarbons (CFCs) aspropellants, such as Combivent MDI. Combivent Respimat uses a spring mechanismto release the medication, rather than a propellant, so it does not releaseCFCs or hydrofluoroalkane (HFA) propellants.

"Combivent Respimat is a testament to ourcompany's dedication and focus on making meaningful developments in respiratorymedicine," said Greg Behar, president and CEO of Boehringer IngelheimPharmaceuticals Inc. "Leveraging our extensive respiratory therapeuticexperience and a long history of bringing innovative medicines to patients, wecontinue to expand our strong clinical program examining the potential ofseveral late-stage investigational compounds also delivered by the Respimatinhaler."

In a 12-week, randomized, double-blind, placeboand active-controlled clinical trial, Combivent Respimat was reportedly shownto be clinically comparable to Combivent MDI, in terms of FEV1, which is themaximal amount of air that can be forcefully exhaled in one second. In thestudy, treatment was administered to patients with COPD four times a day.

Current plans call for Combivent Respimat to beavailable to patients by mid-2012.

To allow adequate time to transition, CombiventMDI will be available until late 2013, but as of Jan. 1, 2014, CombiventRespimat will be the only Combivent product available.

"Boehringer Ingelheim invested more than 10 yearsdeveloping Combivent Respimat," said Dr. Christopher Corsico, senior vicepresident, Medicine and Regulatory for Boehringer Ingelheim PharmaceuticalsInc. "We are committed to ensuring patients and healthcare professionals areaccurately instructed on how to use the new type of inhaler, before CombiventMDI is no longer on the market."

As many as 24 million Americans may have COPD, andit is estimated that half of them remain undiagnosed. COPD is the fourth-leadingcause of death in the United States, killing one person every four minutes andmore people each year than breast cancer and diabetes combined, BoehringerIngelheim notes.

FDA approves Boehringer Ingelheim’s Combivent inhalation spray for the treatment of COPD

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Jeffrey Bouley

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