The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone layer. The company’s latest product contains hydrofluoroalkane propellants, which are permitted under current U.S. law.
“When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product. 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,” Dr. Scott Gottlieb and Dr. Janet Woodcock of the FDA wrote in a prepared statement.
The U.S. regulatory agency stressed that the OTC Primatene Mist product is only designed for people with mild, intermittent asthma and that people with more severe asthma should work with their health care provider to create an appropriate treatment plan.
“Our aim is to empower consumers in their health care decisions and provide access to safe and effective treatment options that can help promote proper care and improve patient outcomes. In doing so we cannot stress enough the importance of seeing a health care provider for any chronic condition to receive a proper diagnosis and be put on a treatment plan that works for each individual patient,” they added.
Primatene Mist is the only FDA-approved asthma inhaler available without a prescription in the U.S., Amphastar touted. The company expects that the device will be available at drugstores across the U.S. by early 2019.
“We are very happy to have received FDA approval for Primatene Mist and are proud to bring this important product back to the over-the-counter (OTC) market in the United States. 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 mission is to develop and bring to market innovative pharmaceutical products and delivery systems that will meaningfully improve peoples’ lives and we believe Primatene Mist will do just that,” CEO Dr. Jack Zhang said in prepared remarks.
AMPH shares were trading at $20.32 apiece in mid-morning activity today, up 5.5%.