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US 2026/0263387 A1Published application
Intranasal epinephrine formulations and methods of use
AssigneeARS Pharmaceuticals Operations, Inc.
InventorRichard LOWENTHAL
Life of this patent
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Abstract
Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.
Claims30
A method of treating a type-1 hypersensitivity reaction in a human comprising intranasally administering to the human with the type-1 hypersensitivity reaction two or more doses of a pharmaceutical formulation of epinephrine, or a salt thereof;
- wherein each dose comprises between about 1.0 mg and about 2.0 mg of epinephrine, or a pharmaceutically acceptable salt thereof, dodecyl maltoside, and water in a volume between about 50 μL and about 200 μL per dose;
- wherein the second dose is intranasally administered within 10 minutes of the first dose;
- wherein each dose is intranasally administered in the same nostril;
- wherein each dose provides plasma epinephrine concentrations in the human that are efficacious for the elimination of, and/or for the prevention of, the further progression of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction in the human;
- or
- wherein the first dose provides inadequate plasma epinephrine concentrations in the human that are efficacious for the elimination of, and/or for the prevention of, the further progression of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction in the human;
- and the intranasal administration of the second dose provides plasma epinephrine concentrations in the human that are efficacious for the elimination of, and/or for the prevention of the further progression of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction in the human.
4 more elements
Dependencies are inferred from the claim text.