Oxymetazoline For The Treatment Of Ano-Rectal Disorders

a technology of anorectal disorders and oxymetazoline, which is applied in the field of treating anorectal disorders, can solve the problems of not being able to find particularly efficient drug therapies for treating anorectal disorders, such as fecal incontinence, and achieve the effects of reducing or preventing fecal incontinence, increasing the resting anal pressure, and high resting anal pressur

Inactive Publication Date: 2014-02-20
RDD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0022]According to yet another embodiment, treating an ano-rectal disorder is selected from the group consisting of: preventing the occurrence of an ano-rectal disorder, reducing or preventing fecal incontinence, increasing the resting anal pressure, maintaining a high resting anal pressure for at least one hour, strengthening the anal sphincter musc

Problems solved by technology

To date, no particularly efficient drug therapy for treating

Method used

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  • Oxymetazoline For The Treatment Of Ano-Rectal Disorders

Examples

Experimental program
Comparison scheme
Effect test

example 1

The Effect of Alpha Agonist on Resting Anal Pressure

[0113]Preparations of phenylephrine hydrochloride and oxymetazoline were prepared. The oxymetazoline was first dissolved in propylene glycol and then added to polyethylene glycol 1500 to obtain a solution in the concentration of 1 mg / 1 mL.

[0114]The preparations were administered intraanally. The doses are expressed as both a volume of a concentration of the drug solution and also as milligrams of the active ingredient.

[0115]Resting anal pressure was determined by anorectal manometry for measuring contractility in the anus and rectum using the ManoScan 360™ catheter (Sierra Scientific Instruments).

[0116]Healthy volunteers, men and women of 18 to 55 years old received intraanal dose of 40 mg (40 mL) or 80 mg (80 mL) phenylephrine or a dose of 1 mg oxymetazoline (1 mL; 0.1%). None of the volunteers had symptoms of anal incontinence nor previous anal surgery and presumed to have intact internal and external anal sphincters. Pre-treatme...

example 2

The Cardiac Effect of Oxymetazoline

[0122]The effect of oxymetazoline on cardiac parameters was examined in four healthy human subjects. The results are presented in the Table 3.

TABLE 3Resting anal pressure and cardiac parametersPhysiologicalOxymetazoline doseparameter0.01%0.1%0.5%Change in resting1118.524.75anal pressure(mmHg)Change in diastolic201blood pressure(mmHg)Change in heart rate−301(beats / min)Change in systolic653Blood pressure(mmHg)

[0123]The change in resting anal pressure with respect to baseline, in response to doses of 0.1% and 0.5%, was statistically significant.

[0124]The results indicate that at the low doses of oxymetazoline are highly effecting in inducing a significant increase in the resting anal pressure, these doses do not induce any cardiovascular side effect.

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Abstract

Methods for treating fecal incontinence by administering to a subject in need thereof compositions including oxymetazoline as an active ingredient. Kits including compositions of oxymetazoline suitable for topical application, for the treatment of fecal incontinence.

Description

FIELD OF THE INVENTION[0001]The present invention provides methods for treating ano-rectal disorders, specifically, fecal incontinence, by administering to a subject in need thereof compositions comprising oxymetazoline as an active ingredient. The present invention further provides kits comprising compositions of oxymetazoline suitable for topical application, for the treatment of ano-rectal disorders.BACKGROUND OF THE INVENTION[0002]Fecal incontinence is a common disorder in men and women, though more prevalent in women. The mechanisms causing anal incontinence usually involve reduced resting tone of the external and internal anal sphincters, and damage in the levator ani muscles, especially, the puborectalis muscle.[0003]Conventional treatments of fecal incontinence include pelvic floor rehabilitation by exercises or surgical interventions and drug therapy. Biofeedback training is one of the treatments involving muscle strengthening exercises to improve anal canal resting and squ...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61K45/06
CPCA61K45/06A61K31/4164A61K9/0031A61K31/4174A61P1/00A61P21/00A61P43/00A61K31/451A61K31/485
Inventor BARAK, NIRRICE, HOWARD LAWRENCE
Owner RDD PHARMA
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