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FMXIN002 in Patients at Risk of Anaphylaxis
Sponsor: Nasus Pharma
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.
Official title: Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-06-12
Completion Date
2026-07-12
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
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
Adrenalin 0.5mg Injectable Product
Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.
Locations (1)
Shamir Medical Center
Be’er Ya‘aqov, Israel