Nonprescription Racemic Epinephrine for Asthma

Background: Inhaled racepinephrine (RE) (Asthmanefrin) became available in September 2012 as a nonprescription treatment for bronchospasm based on a 1986 US Food and Drug Administration rule. It contains 11.25 mg RE in 0.5 mL and is delivered by a handheld electronic nebulizer. In 2001, we conducted a pilot study that was never published. Now that the product is promoted as a replacement for epinephrine chlorofluorocarbon metered-dose inhaler(Primatene), we provide the results of that study. Methacholine challenge was used as a bioassay. Objective: To determine the dose of RE that is equivalent to nebulized albuterol. Methods: Four subjects, 18 to 45 years old, with mild stable asthma completed the pilot study. Methacholine challenge was performed on the first screening day, without pretreatment, andthen on different days, 15 minutes after 1.25 mg albuterol and 2.5, 5, 10, and 20 mg RE delivered by a Pari LC Plus nebulizer. The end point was the provocative concentration of methacholine that caused a 20% decrease in FEV₁. Data were log transformed and analyzed by an ANOVA for repeated measures. Results: There was a significant dose response for RE. Thegeometric mean provocative concentration of methacholine that caused a 20% decrease in FEV₁ was 44 mg/mL (95% CI, 23-85 mg/mL) after albuterol, and 10.2 mg/mL (95%CI, 3.5-30mg/mL) after the 10-mg dose of RE (approximate nonprescription dose) (P= .001). There were noadverse effects. Conclusion: RE provides less bronchoprotection from methacholine than does albuterol and may be less effective in treating acute bronchospasm.