NCT07045701

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

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nasus Pharma · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anaphylaxis Food

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Epinephrine 4mg nasal powder spray	Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection
COMBINATION_PRODUCT	Adrenalin 0.5mg Injectable Product	Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-06-12
• Completion: 2026-07-12
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Israel