FMXIN002 in Patients at Risk of Anaphylaxis

Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis

Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis.

Study Design

• Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.

Study Procedures

1. Informed Consent: Participants will sign consent forms.

2. Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.

3. Assessment: At the first signs of allergic symptoms, a physician will assess the subject.

4. Treatment Criteria: If a Grade II or III anaphylactic reaction occurs, the participant will receive either:

   A). Intranasal spray of epinephrine FMXIN002 4mg + placebo saline injection B). Intranasal spray of placebo + intramuscular epinephrine injection (Adrenalin 0.5mg)

   One administration will always be epinephrine; the other, placebo.

5. Randomization: 1:1 between the 2 study arms.

6. Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.

7. Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).

8. Supportive Treatment: All participants will receive antihistamines (Fenistil drops + fexofenadine 180 mg or desloratadine 5 mg). Inhaled bronchodilators (e.g., Ventolin) will be provided for respiratory symptoms as needed.

9. Monitoring: Assessments at baseline, symptom onset, and at 3, 5, 10, 15, 30, and 90 minutes post-treatment. Vital signs and system-based symptom assessments will be recorded (Appendix 3).

10. Rescue Therapy: If no improvement in 3-5 minutes, a second IM epinephrine dose (0.5 mg) will be given. Further treatment will follow standard anaphylaxis protocols

11. Discharge: Participants with symptom resolution by 90 minutes will be discharged.

Inclusion Criteria:

• Age 18-40 years, any gender
• Documented or suspected food allergy (based on IgE level or clinical history)
• Development of Grade II or III reaction during OFC

Exclusion Criteria:

• Age <18 or >40
• Poorly controlled asthma (FEV1 < 80% or frequent symptoms)
• Active eosinophilic esophagitis
• Pregnancy or risk of pregnancy
• Mild (Grade I) or very severe (Grade IV) reactions during OFC
• Decline to participate