Nasal Spray Epinephrine Shown to Be Bioequivalent, Effective

Epinephrine administered via a nasal spray could be an effective alternative to injectors in treating anaphylaxis, according to research intended to be presented at the American Academy of Allergy, Asthma, & Immunology Annual Meeting.

Three studies were conducted to measure the effectiveness of the needle-free alternative. 

“There’s a stigma associated with needles, and fears over administrating epinephrine to oneself or someone else can cause delays in medication administration. These delays can lead to emergency situations that can put the patient in real danger,” said Richard F Lockey, MD, FAAAAI, one of the authors of the three studies. “Based on these results, nasal spray epinephrine has the potential to be a needle-free alternative to intramuscular epinephrine and could help to alleviate some of those delays in treatment.” 

In the first study, researchers evaluated dosing methods to assess the pharmacokinetics of epinephrine in 36 patients. Patients either received a 1 mg dose of epinephrine nasal spray, a 0.3 mg or 0.5 mg dose given by intramuscular injection, and a subcutaneous administration.

“[Nasal spray epinephrine was more] rapidly absorbed than administration by needle and syringe. The hemodynamic response (a greater or more rapid increase in systolic blood pressure and heart rate) saw significant improvements with the epinephrine nasal spray,” noted AAAAI in a press release. 

The second study found that epinephrine nasal spray delivered a more consistent exposure and hemodynamic response within the first 20 minutes compared to intramuscular in 70 healthy randomized adults. 

The third study included the “administration of a single and repeat (twice) dose of 1 mg epinephrine nasal spray compared to single and repeat 0.3mg EpiPen injection in 36 subjects, with blood pressure and heart rate measurements taken every five minutes.”

The nasal spray alternative was again found to have bioequivalent exposure and an increased absorption rate.

“Epinephrine nasal spray has shown promise in these completed studies,” Dr Lockey concluded. “With a lack of serious adverse events, comparable rates of absorption and the consistent reliability when it comes to delivery, the ARS-1 product, which will be called Neffy, represents a step forward in patient care for the treatment of severe systemic allergic reactions to help prevent anaphylaxis.”

All three studies reported minimal adverse effects, noting that the nasal epinephrine alternative was well-tolerated and did not cause any significant nasal pain or irritation. —Edan Stanley