Nov. 9 (UPI) -- Primatene Mist, the only FDA-approved asthma inhaler available without a prescription in the United States, was taken off the market worldwide in 2011 because it contained chlorofluorocarbon propellants. It was pursuant to the Montreal Protocol, an international environmental treaty, which phased out products worldwide containing ozone-depleting CFCs
This new version contains hydrofluoroalkane propellants, which are permitted under international and U.S. law, the FDA said in a press release Thursday. Prescription-only inhalers that use different medications, including albuterol and levalbuterol, also use HFAs as propellants.
Amphastar, the manufacturer of the epinephrine inhalation aerosol bronchodilator suspension, plans to launch the product in pharmacies early next year.
"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," Amphastar's CEO Dr. Jack Zhang said in a press release.
The new patented formulation contains the same active ingredient as the original Primatene Mist. It features a built-in spray indicator and metal canister, replacing the glass container of the original Primatene Mist. It delivers 0.125mg per spray and contains 160 metered sprays.
It's used for wheezing, tightness of chest and shortness of breath in patients 12 and older.
"When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product," Dr. Scott Gottlieb, commissioner of the FDA, said in a statement. "Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment. At the same time, we also heard from practitioners concerned with the product remaining on the market."
Concerns included being "harmed by self-medicating with an OTC product," rather than appropriate asthma care that includes the appropriate use of inhaled corticosteroids or other controller medications to reduce inflammation and the incidence of exacerbations.
Gottlieb said the agency has taken measure of these concerns and the potential risks of an OTC product -- specifically whether it could forestall treatment for people with long-term, chronic asthma who need care from a medical professional.
"Patients with more severe asthma should not rely on it," Gottlieb said. "Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition. You'll see that this risk is addressed in the instructions on how to use the product safely and a warning to seek medical care if the patient is using it regularly as overuse of the product is a risk."
Consumers should discuss asthma diagnoses and treatments with their health care providers before using any new asthma product, Gottlieb said.
The new product also looks different and has updated instructions for use that consumers need to follow for the inhaler to work properly.
"We have learned new information about the appropriate treatment for asthma in the intervening years since this product was withdrawn from the market, the risks and benefits of different medications, and the potential role that Primatene Mist can play," Gottlieb said.