Pharmacology of Anal Application of Oxymetazoline in Humans
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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2019
- Accession Number
- AD1094818
Entities
People
- Nir Barak