Unmet Needs and Challenges in Allergy Management - Episode 4
Part 4 highlights how expanding epinephrine delivery options can reduce barriers, support earlier administration, and improve real-world anaphylaxis outcomes.
Part 4 of the special report explores one of the most rapidly evolving areas in anaphylaxis care: the expanding range of epinephrine delivery options and their potential to overcome long-standing barriers to timely treatment. Panelists reviewed both currently available products and emerging alternatives that may reshape how patients carry and use epinephrine.
The discussion began with a review of injectable options. In the United States, epinephrine autoinjectors are available in 0.1 mg, 0.15 mg, and 0.3 mg doses, while a 0.5 mg autoinjector is available in Europe but not yet in the US. Golden noted that this raises concerns about underdosing in larger adults and underscores the importance of promptly administering a second 0.3 mg dose if symptoms do not improve. Using weight-based dosing (0.01 mg/kg), a 0.3 mg dose is theoretically appropriate for a patient weighing approximately 30 kg (66 pounds), highlighting the need for repeat dosing in adolescents and adults with severe reactions.
Both experts emphasized that syringe-and-needle intramuscular epinephrine remains appropriate in healthcare settings, where dosing can be precisely tailored, even though autoinjectors achieve faster absorption in pharmacokinetic studies. However, many of the persistent gaps in anaphylaxis outcomes stem not from pharmacology but from human factors, including fear of needles, reluctance to carry devices, uncertainty about diagnosis, and hesitation to use epinephrine early.
The panel highlighted the significance of newly approved and emerging non-injectable options. Golden described the first FDA-approved intranasal epinephrine spray (neffy), which has been on the market for over a year.1 Because placebo-controlled anaphylaxis trials are not feasible, approval relied on pharmacokinetic data demonstrating plasma epinephrine levels comparable to existing intramuscular products.2 The nasal spray falls within the therapeutic range between manual intramuscular injection and autoinjectors, and early real-world experience has been encouraging.
The experts discussed additional products in development, including other nasal formulations and a sublingual oral film (Anaphylm) using a prodrug approach to overcome epinephrine’s absorption challenges.3 Lieberman noted that many patients strongly prefer oral medications, making a sublingual option particularly appealing if efficacy is maintained. Newer formulations may also offer practical benefits such as longer shelf life and greater temperature stability.
In closing, Golden and Lieberman returned to the core message of the entire series. Improving anaphylaxis outcomes requires earlier epinephrine use, fewer barriers to administration, and abandoning outdated reliance on antihistamines and corticosteroids in acute care. As Lieberman summarized succinctly: “Epinephrine, epinephrine. Let's stop using steroids for anaphylaxis, and let's use epinephrine early on and get rid of barriers to use.”
Experts include:
Brian Schroer, MD, of Cleveland Clinic Children’s Hospital
Jay Lieberman, MD, of the University of Tennessee Health Science Center
David Golden, MD, of Johns Hopkins University
Disclosures include Novartis Pharmaceuticals, Regeneron Pharmaceuticals, BioCryst, GlaxoSmithKline, Amgen, GENZYME Corporation, AstraZeneca Pharmaceuticals, and LEO Pharma for Schroer; Novartis Pharmaceuticals, ABBVIE, Genentech, Aquestive Therapeutics for Lieberman; and Phadia US and Genentech USA for Golden.
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