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FDA reapproves OTC Primatene Mist for mild asthma
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The FDA has approved over-the-counter Primatene Mist to temporarily relieve symptoms of mild, intermittent asthma in patients aged 12 years and older, according to a press release.
In the United States, Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension, Amphastar Pharmaceuticals Inc.) is the only asthma inhaler that is FDA-approved and available without a prescription, according to the release. The metered dose inhaler delivers a non-chlorofluorocarbon propellant, according to the release.
In 2011, the inhaler was removed from the market because it contained a chlorofluorocarbon propellant that was known to deplete the ozone layer, according to the release. The new formula uses the same active ingredient, epinephrine, but does not include ozone-depleting ingredients, according to the release.
“We are very happy to have received FDA approval for Primatene Mist and are proud to bring this important product back to the OTC market in the United States,” Jack Zhang, PhD, CEO of Amphastar, said in the release. “We are grateful to the FDA team for working closely with us to make this approval possible, recognizing the important role of OTC bronchodilator drugs such as Primatene Mist.”
The new delivery system includes novel features, such as a built-in spray indicator and a metal canister, according to the release.
“As the OTC product is being reintroduced, we’ve taken these steps to make sure those concerns were taken into account,” Scott Gottlieb, MD, FDA Commissioner, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, said in a joint statement.
“Making sure that patients can understand and apply the instructions for use was a critical consideration for the FDA,” they said. “The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Patients with more severe asthma should not rely on it.”
The new version replaces chlorofluorocarbon propellants with hydrofluoroalkane propellants, which are currently permitted, they said.
Epinephrine inhalation aerosol bronchodilator suspension is not associated with any serious safety concerns when used as directed, according to Gottlieb and Woodcock.
The American College of Allergy, Asthma and Immunology warns against stopping prescription asthma medication for Primatene Mist.
“Asthma is not a ‘do-it-yourself’ disease that you can treat yourself with OTC medications,” Bradley Chipps, MD, president of the American College of Allergy, Asthma and Immunology said in a press release. “Anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control their disease. People should understand they shouldn’t go off their regular prescription medication to start taking Primatene Mist instead. That could prove very dangerous.”
Disclosures: Chipps is president of the American College of Allergy, Asthma and Immunology. Gottlieb and Woodcock are employed by the FDA. Zhang is CEO of Amphastar Pharmaceuticals Inc.