US 11,911,380 B2
Compositions and use of varenicline for treating dry eye
Douglas Michael Ackermann, Jr., Reno, NV (US); James Loudin, Houston, TX (US); and Kenneth J. Mandell, Lexington, MA (US)
Assigned to Oyster Point Pharma, Inc., Princeton, NJ (US)
Filed by Oyster Point Pharma, Inc., Princeton, NJ (US)
Filed on Mar. 23, 2023, as Appl. No. 18/125,551.
Application 18/125,551 is a continuation of application No. 17/543,505, filed on Dec. 6, 2021.
Application 17/543,505 is a continuation of application No. 16/566,237, filed on Sep. 10, 2019, granted, now 11,224,598, issued on Jan. 18, 2022.
Application 16/566,237 is a continuation of application No. 15/422,382, filed on Feb. 1, 2017, granted, now 10,456,396, issued on Oct. 29, 2019.
Application 15/422,382 is a continuation of application No. 14/887,248, filed on Oct. 19, 2015, granted, now 9,597,284, issued on Mar. 21, 2017.
Claims priority of provisional application 62/100,844, filed on Jan. 7, 2015.
Claims priority of provisional application 62/066,280, filed on Oct. 20, 2014.
Prior Publication US 2023/0226053 A1, Jul. 20, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4995 (2006.01); A61K 31/4439 (2006.01); A61K 45/06 (2006.01); A61K 9/00 (2006.01); A61K 31/439 (2006.01); A61K 31/4427 (2006.01); A61K 9/08 (2006.01); A61K 31/4985 (2006.01)
CPC A61K 31/4995 (2013.01) [A61K 9/007 (2013.01); A61K 9/0043 (2013.01); A61K 9/0048 (2013.01); A61K 9/08 (2013.01); A61K 31/439 (2013.01); A61K 31/4427 (2013.01); A61K 31/4439 (2013.01); A61K 31/4985 (2013.01); A61K 45/06 (2013.01)] 30 Claims
 
1. A method of activating a trigeminal nerve in an individual in need thereof comprising administering a therapeutically effective amount of varenicline to the individual, wherein said administration is local administration of a spray of a liquid pharmaceutical formulation comprising a solution of varenicline or a pharmaceutically acceptable varenicline salt and one or more pharmaceutically acceptable inactive ingredients, wherein the concentration of varenicline in the formulation is between about 0.1 mg/mL and about 10 mg/mL, into a nasal cavity of the individual, wherein the therapeutically effective amount of varenicline administered into the nasal cavity is between 5 micrograms and 1000 micrograms.