US 11,744,895 B2
Intranasal epinephrine formulations and methods for the treatment of disease
Richard Lowenthal, San Diego, CA (US); Edward T. Maggio, San Diego, CA (US); Robert G. Bell, San Diego, CA (US); and Pratik Shah, San Diego, CA (US)
Assigned to AEGIS THERAPEUTICS, LLC, San Diego, CA (US)
Filed by Aegis Therapeutics, LLC, San Diego, CA (US)
Filed on Aug. 6, 2021, as Appl. No. 17/396,044.
Application 17/396,044 is a continuation of application No. 16/869,461, filed on May 7, 2020, granted, now 11,191,838.
Application 16/869,461 is a continuation of application No. 16/420,044, filed on May 22, 2019, granted, now 10,682,414, issued on Jun. 16, 2020.
Application 16/420,044 is a continuation of application No. PCT/US2019/016918, filed on Feb. 6, 2019.
Claims priority of provisional application 62/784,057, filed on Dec. 21, 2018.
Prior Publication US 2021/0361770 A1, Nov. 25, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/26 (2006.01); A61K 31/7016 (2006.01); A61K 31/485 (2006.01); A61K 9/00 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 31/485 (2013.01); A61K 31/7016 (2013.01); A61K 9/006 (2013.01); A61K 9/0043 (2013.01); A61K 9/0048 (2013.01); A61K 9/0056 (2013.01)] 26 Claims
 
1. A method of treatment of a type-1 hypersensitivity reaction in a human comprising an intranasal administration of a pharmaceutical formulation comprising between about 0.1 mg and about 2.4 mg of epinephrine, or a salt thereof, in a single administered dose to the human with the type-1 hypersensitivity reaction;
wherein epinephrine, or a salt thereof, is the only pharmaceutically active ingredient in the pharmaceutical formulation; and
wherein the intranasal administration of the single administered dose of the pharmaceutical formulation to the human provides plasma epinephrine concentrations in the human that are efficacious for the elimination of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction; or
wherein the intranasal administration of the single administered dose of the pharmaceutical formulation to the human provides plasma epinephrine concentrations in the human that are efficacious for the prevention of the further progression of one, more than one, or all of the symptoms of the type-1 hypersensitivity reaction.