Acute Anaphylaxis Guideline Updates

The recent updates to the acute anaphylaxis guideline have highlighted the need for improved therapeutic options to address existing gaps in care as a top priority.

Study Findings

According to a study published in The Journal of Allergy and Clinical Immunology: Global, researchers have concluded that NDS1C offers a needle-free, user-friendly solution for self-administering epinephrine. This is better than the 0.3 mg autoinjector to address unmet medical and patient needs.

This study compares the pharmacokinetic, pharmacodynamic, safety, and tolerability profiles of intranasal and intramuscular epinephrine. One hundred sixteen healthy adults received 13.2 mg intranasal epinephrine, 0.3 mg autoinjector, or 0.5 mg manual syringe intramuscular epinephrine. Participants with 50, 100, and 200 pg/mL epinephrine concentrations were evaluated at 10-, 20-, 30-, and 60 minutes post-dose.

Study Results

• PK parameters for the 13.2 mg IN dose exceeded those of the 0.3 mg autoinjector with a rapid and higher Cmax and greater systemic exposure.
• The maximum concentration of epinephrine for intranasal spray was 429.4 pg/mL, and for autoinjector was 328.6 pg/mL.
• PK parameters for opposite and same nostril dosing were higher than both intramuscular doses except Tmax, which was between the two intramuscular doses (20 min for intranasal, 14.9 min for autoinjector, and 45 min for manual syringe).
• Of the 54 participants, 27 achieved the same epinephrine levels as the autoinjector after opposite-nostril administration in approximately 8.2 minutes, while 33 of the 49 participants with same-nostril administration reached the same levels in 6.2 minutes.
• No severe or unexpected adverse events were reported, confirming the safety and tolerability of intranasal epinephrine.

About NDS1C

NDS1C, a nasal spray developed by Bryn Pharmaceutics, delivers epinephrine without requiring a needle. Its compact size makes it easily portable and can be used without specialized medical training. This product aims to provide the allergy community a treatment option similar to the EpiPen autoinjector, currently the preferred treatment for outpatients.

Reference

Dworaczyk, et al. 13.2 mg Intranasal Epinephrine Spray Demonstrates Comparable Pharmacokinetics, Pharmacodynamics, and Safety to 0.3 mg Epinephrine Autoinjector. Journal of Allergy and Clinical Immunology: Global, 100200.