Claims for Patent: 11,744,838

Summary for Patent: 11,744,838

Title:	Methods of treating hypogonadism with transnasal testosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Abstract:	The present invention relates to methods of treating hypogonadism in a male subject through administering intranasally to the male subject an intranasal testosterone bio-adhesive gel formulation to deliver a therapeutically effective amount of testosterone. In particular, the testosterone therapy of the invention remains effective if an allergic rhinitis event occurs in the male during the treatment or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.
Inventor(s):	Natalia Tkachenko
Assignee:	Acerus Biopharma Inc
Application Number:	US16/532,776
Patent Claims:	1. A method of treating a male, who is experiencing symptomatic allergic or seasonal rhinitis, with testosterone replacement therapy for a condition associated with a deficiency or absence of endogenous testosterone who is in need of such testosterone replacement treatment, the method comprising: administering intranasally to the symptomatic male three times a day an intranasal testosterone gel to deliver intranasally to the symptomatic male a total daily dose of about 33 mg of testosterone to effectively treat said condition in the symptomatic male wherein said condition is hypogonadism; and providing a metered dose pump containing 11 grams of the intranasal testosterone gel, wherein the metered dose pump dispenses 60 metered pump actuations, wherein one pump actuation delivers 5.5 mg of the testosterone in 0.122 grams of the intranasal testosterone gel, so that, when the symptomatic male actuates the one said pump from the metered dose pump into each nostril of the symptomatic male three times a day, the total daily dose of about 33 mg of testosterone is intranasally administered to the symptomatic male. 2. An intranasal testosterone method for treating a male, who is symptomatic for allergic or seasonal rhinitis, with testosterone replacement therapy for a condition associated with a deficiency or absence of endogenous testosterone that is in need of such testosterone replacement treatment, said method comprising: providing a metered dose pump containing 11 grams of an intranasal testosterone gel, wherein the metered dose pump dispenses 60 metered pump actuations of the intranasal testosterone gel; and instructing the symptomatic male to actuate one pump from the metered dose pump into each nostril of the symptomatic male three times a day to deliver intranasally to the symptomatic male a total daily dose of about 33 mg of testosterone to effectively treat the symptomatic male for the condition; wherein the one pump actuation delivers 5.5 mg of the testosterone in 0.122 grams of the intranasal testosterone gel into each of the nostrils; wherein the condition is hypogonadism; and wherein the hypogonadism is selected from a group of hypogonadisms consisting of congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism.