FDA approves CFC-free COPD spray

New inhaler releases medicine without aerosol propellant

October 12, 2011 / Author:  / Reviewed by: Joseph V. Madia, MD

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(dailyRx News) This week, the Food and Drug Administration (FDA) announced its approval of a new inhaler for chronic obstructive pulmonary disease (COPD).

The treatment was developed in response to the Montreal Protocol, which requires the phase-out of substances using chlorofluorocarbons (CFCs). CFCs are known to deplete the ozone layer.

"Ask your pharmacist about new, non-aerosol treatment for COPD."

The inhaler features a combination of two drugs, released in a slow-moving spray. Ipratropium bromide opens the bronchi, a passage of airway in the respiratory tract that moves air into the lungs. Albuterol sulfate is a bronchodilator that relaxes muscles in the airways to increase air flow to the lungs.

According to a statement from Boehringer Ingelheim Pharmaceuticals, Inc., the treatment's maker, the combination of these two drugs is more effective than either alone.

Those medications are currently available in an inhaler called Combivent MDI, which uses CFCs, and will be phased out in 2013. The new treatment, called Combivent Respimat, will be available in mid-2012. Combivent Respimat requires only a single inhalation for each dose, and features a dose indicator to show the amount of medication remaining.

In a 12-week clinical trial, Combivent Respimat was shown to be comporable to the Combivent MDI, in terms of the maximum amount of air that can be forcefully exhaled in one second, according to the pharmaceutical company's statement.

This treatment is not recommended to patients who are sensitive to the components of the drugs used, or soya lecithin and related food products such as soybean and peanut. Adverse effects include life-threatening paradoxical bronchospasm, urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

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Review Date: 
October 12, 2011
Last Updated:
October 12, 2011