The US Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product for use in patients with chronic obstructive pulmonary disease (COPD), developed by [removed]Boehringer Ingelheim Pharmaceuticals Inc[/removed]. The inhaler, which uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered does (COMBIVENT MDI), is indicated for COPD patients on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
COMBIVENT RESPIMAT will be available to patients by prescriptions starting in mid-2012.
In a 12-week, randomized, double-blind, placebo and active-controlled clinical trial, COMBIVENT RESPIMAT was found to be clinically comparable to COMBIVENT MDI in terms of FEV1. In the study, COPD patients received treatment four times a day.
COMBIVENT RESPIMAT requires one inhalation per dose as compared to COMBIVENT MDI, which requires two inhalations per dose. COMBIVENT RESPIMAT also features a dose indicator to inform patients of the amount of remaining medication in the 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.
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.
Source: Boehringer Ingelheim Pharmaceuticals Inc