The Race For An OTC Asthma Inhaler

The looming effective date for an FDA ban on the Primatene over-the-counter inhaler due to its chlorofluorocarbons (CFCs) that deplete the ozone layer has generated an increased media interest in the past week, as it is the only over-the-counter asthma inhaler being phased out.

Chlorofluorocarbons (CFCs), found in solvents and refrigerants as well as propellants (such as aerosol), are being phased out internationally by the Montreal Protocol, which was designed to protect the ozone layer by phasing out substances known to cause ozone depletion. The United States created provisions to adhere to the Montreal Protocol in the Clean Air Act Amendments of 1990.  In 2005 the FDA removed the “essential use” designation for albuterol used in oral pressured metered-dose inhalers, which contain CFCs. The effective date for this rule was December 31st, 2008. In 2010 the FDA announced another seven metered-dose inhalers were being phased out due to CFCs, including the Primatene inhaler. According to the FDA, as the phasing out of CFCs has grown;

Many manufacturers have changed their inhalers to replace CFCs with a propellant called hydrofluoroalkane (HFA). For instance, albuterol HFA inhalers can be used in the same way you use epinephrine CFC inhalers. You can only buy albuterol HFA inhalers—or any inhaler after Dec. 31—with a prescription from your doctor. There is currently no over-the-counter or prescription epinephrine inhaler made without CFCs.

 

As the final stages of this phase out approach, the race is on for a pharmaceutical manufacturer to come out with an over-the-counter inhaler for patients in the United States.