Accession Number:

AD1094818

Title:

Pharmacology of Anal Application of Oxymetazoline in Humans

Descriptive Note:

Technical Report,15 Aug 2017,14 Jun 2019

Corporate Author:

RDD Pharma, Inc New York United States

Personal Author(s):

Report Date:

2019-10-01

Pagination or Media Count:

10.0

Abstract:

Fecal incontinence in patients with spinal cord injury is a devastating disease, causing increased morbidity and mortality, especially due to its relation to pressure ulcers in the buttock area and to severe infections. In spinal cord injury, neural signals that travel through the spine, cannot reach their designated muscles. Lack of signals to the rectal sphincter muscle cause fecal incontinence, as this muscle is no longer contracted. The purpose of this project was to investigate the drug effect of oxymetazoline, applied intra-anally, on safety, drug levels and bowel movements in healthy subjects. The results show that at the highest dose found safe 1 the drug levels were within FDA approved acceptable range, and 2 reduction in the frequency of bowel movements and increased sphincter pressure were observed. These results 1 establish the safety and potential efficacy of anal application of oxymetazoline 2 show that contraction of the sphincter with this drug, results in fewer bowel movements and 3 will enable RDD Pharma to advance to clinical studies in patients with fecal incontinence due to spinal cord injury.

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE