First-in-class intranasal epinephrine spray for anaphylaxis: Dose finding clinical study

Area of Science:

• Pharmacology
• Allergy and Immunology
• Drug Delivery Systems

Background:

• Anaphylaxis is a severe, life-threatening allergic reaction requiring immediate epinephrine treatment.
• Current epinephrine autoinjectors face usability challenges, hindering timely administration.
• FMXIN002 presents a novel, needle-free nasal dry powder epinephrine formulation as an alternative treatment.

Purpose of the Study:

• To evaluate the pharmacokinetics, pharmacodynamics, and safety of FMXIN002 (3.6 and 4.0 mg) compared to a standard intramuscular (IM) epinephrine autoinjector (0.3 mg).
• To assess the stability of the FMXIN002 formulation.

Main Methods:

• An open-label, single-dose, 3-treatment, crossover, randomized bioavailability study.
• Involved 12 healthy adult participants (male and female).
• Included stability testing of FMXIN002 under various conditions.

Main Results:

• FMXIN002 4.0 mg showed faster and greater epinephrine absorption in most subjects compared to IM autoinjector.
• 91% of subjects reached the therapeutic epinephrine threshold with FMXIN002 4.0 mg versus 55% with IM autoinjector.
• FMXIN002 4.0 mg demonstrated significantly higher plasma epinephrine levels in the initial minutes post-administration (P = .0377).
• Pharmacodynamic response and safety profiles were comparable across all treatments, with mild, self-resolving adverse events.
• FMXIN002 exhibited high stability, including 5 years at 20 ± 5ºC.

Conclusions:

• FMXIN002 4.0 mg nasal spray provides rapid and enhanced epinephrine absorption within the critical therapeutic window for anaphylaxis.
• The needle-free, stable, and safe device offers a patient-friendly alternative for emergency allergy treatment.