Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals’ Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for over the counter sales in the US. The approval is limited to the temporary relief of mild, intermittent asthma symptoms in people aged 12 and over.
The new Primatene Mist has been reformulated with HFA propellant and includes changes to the device including a dose counter and a metal canister instead of the original glass canister. According to Amphastar, the inhaler will be available in the US in early 2019.
A previous effort to get approval for a reformulated Primatene Mist failed when the FDA issued a complete response letter at the end of 2016. The FDA’s Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) had voted against approval of an NDA for a reformulated product due to safety concerns in 2014.
A statement from FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock notes both the great demand for an OTC asthma inhaler from consumers and objections to the availability of an OTC inhaler from clinicians and other groups. The statement also acknowledges that some safety issues remain of concern and emphasizes that Primatene Mist is not a substitute for prescription asthma medications.
Gottlieb and Woodcock said, “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have learned new information about the appropriate treatment for asthma in the intervening years since this product was withdrawn from the market, the risks and benefits of different medications, and the potential role that Primatene Mist can play. All of this information informed our assessment of the risks and benefits of this product and our decision to approve the reformulated version for OTC use. 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.”
Amphastar CEO Jack Zhang said, “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.”
Read the Amphastar Pharmaceuticals press release.
Read the FDA statement.
