Treatment of vulvovaginal disorders

Patent metadata

Field	Value
Publication number	US-2022040136-A1
Application number	US-201917280638-A
Country	US
Kind code	A1
Filing date	Oct 2, 2019
Priority date	Oct 9, 2018
Publication date	Feb 10, 2022
Grant date	—

Abstract

The present invention relates to methods of treating vulvovaginal disorders, including female reproductive tract irritation (such as pain and pruritus) or/and inflammation.

First claim

1 . A method of treating a vulvovaginal disorder or reducing or preventing lower genital tract irritation in a subject, the method comprising administering an effective amount of a pro-resolving mediator topically to a treatment site of the subject's lower genital tract.

2 . The method of claim 1 , wherein the irritation is pain or pruritus associated with a genital tract inflammatory condition.

3 . The method of claim 2 , wherein the genital tract inflammatory condition is selected from the group consisting of localized provoked vulvodynia (LPV), lichen planus, lichen sclerosus, desquamative inflammatory vaginitis, atrophic vulvovaginitis associated with breast cancer, and chronic pruritus.

4 . The method of claim 2 , wherein the genital tract inflammatory condition is LPV.

5 . The method of claim 1 , wherein the pro-resolving mediator is administered at 0.0001 mg/kg-100 mg/kg.

6 . The method of claim 1 , wherein the pro-resolving mediator is administered once a week, 2-3 times a week, once a day, twice a day, or three times a day.

7 . The method of claim 1 , wherein the pro-resolving mediator is administered before the subject is exposed to a secondary irritation-causing stimulation.

8 . The method of claim 1 , wherein the treatment site comprises the vulvar vestibule.

9 . The method of claim 1 , wherein the treatment site comprises the external vulva, vestibule, or vagina.

10 . The method of claim 9 , wherein the treatment site comprises the external vulva.

11 . The method of claim 1 , wherein the pro-resolving mediator is selected from the group consisting of Resolvin D 2 , Resolvin D 3 , Resolvin D 4 , Resolvin D 5 , Resolvin E 1 , Maresin-1, epi-Maresin-1, Lipoxin A 4 , Protectin D1, Protectin DX, 14(S)-hydroxy docosahexaenoic Acid (14(S) HDHA), 17(S)-hydroxy docosahexaenoic acid, (17(S) HDHA), 18-hydroxyeicosapentaenoic acid (18-HEPE), docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), arachidonic acid (AA), omega-3 fatty acid, omega-6 fatty acid, fish oil, an fish oil extract and, a mixture thereof.

12 . The method of claim 11 , wherein the pro-resolving mediator is selected from the group consisting of Resolvin D 2 , Resolvin D 3 , Resolvin D 4 , Resolvin D 5 , Resolvin E 1 , Maresin-1, epi-Maresin-1, Lipoxin A 4 , Protectin D1, and Protectin DX.

13 . The method of claim 11 , wherein the mixture comprises DHA, 14-HDHA, 17-HDHA, and 18-HEPE.

14 . The method of claim 1 , further comprising administering a second therapeutic agent to the subject.

15 . The method of claim 14 , wherein the second therapeutic agent is a second pro-resolving mediator.

16 . The method of claim 14 , wherein the second therapeutic agent is an anti-microbial agent or an antiviral agent.

Assignees

• Univ Rochester

Inventors

• Foster David
• Falsetta Wood Megan L
• Phipps Richard P

Classifications

• A61K31/202 Primary

  having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61P15/02

  for disorders of the vagina · CPC title

• A61K35/60

  Fish, e.g. seahorses; Fish eggs · CPC title

• A61K9/0034

  Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants · CPC title