FDA approves Combivent Respimat for COPD
Boehringer Ingelheim Pharmaceuticals has reported that the 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.