Nonprescription Epinephrine Metered-Dose Inhaler: To Be or Not To Be.

A new product, Epinephrine HFA, is being considered by the Food and Drug Administration (FDA) for marketing approval as a nonprescription bronchodilator inhaler for the treatment of the "temporary relief of mild symptoms of intermittent asthma in adults and children 12 years of age and older." This product would serve as a replacement for Primatene® Mist, which was removed from the market in December 2011 in accordance with the requirements of the Montreal Protocol to phase out chlorofluorocarbon (CFC) propellants. The Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee met in early 2014 to review the clinical data. The data indicate that Epinephrine HFA provides improvement in lung function at the proposed doses and that no clinically important safety issues were observed. There were, however, concerns that the device could malfunction and that the dose-counter could lose accuracy. These device issues are significant for a drug that could be used for life-threatening symptoms of asthma. All study data presented are publically available from the FDA website at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm for the February 24, 2014, meeting.