	US 12,233,055 B2
	Topical Montelukast formulations
Vered Rosenberger, Givatayim (IL); Helena Shifrin, Rehovot (IL); Irena Oleinik, Karmiel (IL); Tzviel Sheskin, Haifa (IL); Ron Schlinger, Tel Aviv (IL); and Avi Avramoff, Haifa (IL)
Assigned to TARO PHARMACEUTICAL INDUSTRIES LTD., Haifa Bay (IL)
Filed by TARO PHARMACEUTICAL INDUSTRIES LTD., Haifa Bay (IL)
Filed on Aug. 2, 2021, as Appl. No. 17/391,813.
Application 17/391,813 is a continuation in part of application No. 17/165,574, filed on Feb. 2, 2021, granted, now 11,173,117.
Claims priority of provisional application 63/080,744, filed on Sep. 20, 2020.
Claims priority of provisional application 62/969,333, filed on Feb. 3, 2020.
Prior Publication US 2021/0393613 A1, Dec. 23, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/47 (2006.01); A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 47/10 (2017.01); A61P 17/04 (2006.01)

CPC A61K 31/47 (2013.01) [A61K 9/0014 (2013.01); A61K 9/1075 (2013.01); A61K 47/10 (2013.01); A61P 17/04 (2018.01)]

11 Claims

1. A method of treating atopic dermatitis (AD) in a population of subjects, the method comprising administering a topical pharmaceutical composition comprising 6.5% of Montelukast to a subject in the population of subjects, wherein the administration of the composition results in an improvement in one or more of the following parameters:

a. a decrease from baseline in mean Investigator's Global Assessment (IGA) score of at least 20%;

b. a decrease from baseline in mean % Body Surface Area (BSA) affected score of at least 20%;

c. a decrease from baseline in mean Erythema score of at least 20%;

d. a decrease from baseline in mean Induration score of at least 15%;

e. a decrease from baseline in mean Lichenification score of at least 25%; and

f. a decrease from baseline in mean Pruritus score of at least 20%.