US 11,717,571 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 Oct. 26, 2022, as Appl. No. 18/49,936.
Application 18/049,936 is a continuation of application No. 17/396,044, filed on Aug. 6, 2021.
Application 17/396,044 is a continuation of application No. 16/869,461, filed on May 7, 2020, granted, now 11,191,838, issued on Dec. 7, 2021.
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 2023/0085636 A1, Mar. 23, 2023
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)] 30 Claims
 
1. A method of treating a type-1 hypersensitivity reaction in a human comprising an intranasal administration of a nasal spray pharmaceutical formulation to the human with the type-1 hypersensitivity reaction, wherein a single intranasally administered dose of the nasal spray pharmaceutical formulation comprises:
a) between 0.1 mg and about 2.4 mg of epinephrine, wherein epinephrine is the only pharmaceutically active ingredient in the nasal spray pharmaceutical formulation;
b) one or more other agents as excipients selected from the group consisting of absorption enhancement agents, isotonicity agents, stabilizing agents, antioxidants, preservatives, and pH adjustment agents; and
c) water;
wherein the nasal spray pharmaceutical formulation has a pH between about 3.0 and about 5.0;
wherein the volume of the single intranasally administered dose of the nasal spray pharmaceutical formulation is between 25 μL and 250 μL;
wherein the intranasal administration of the nasal spray pharmaceutical formulation to the human with the type-1 hypersensitivity reaction 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 in the human; or
wherein the intranasal administration of the nasal spray pharmaceutical formulation to the human with the type-1 hypersensitivity reaction 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 in the human.