Pharmacology of Anal Application of Oxymetazoline in Humans
Abstract
RDD Pharma is developing a new formulation of Oxymetazoline (OX), intended to treat spinal cord injury (SCI)-associated fecal incontinence (FI), a devastating complication occurring in 75% of patients that have undergone SCI. Bowel dysfunction among SCI patients significantly impacts quality of life, as manifested by restrictions on diet (80%), outdoor mobility (64%), and overall dissatisfaction with bowel care (62%). Current treatment options for this condition are lacking. Based on the symptoms associated with FI, it is evident that restoring anal pressure to normal levels is expected to reduce death and to improve the overall health condition of these patients. Hypothesis: An ointment formulation of OX will: (1) be safe and well tolerated when applied topically, (2) remain localized, (3) not penetrate the bloodstream to a significant extent, and (4) produce a substantial and sustained increase in anal muscle tone. RDD has demonstrated the safety of topical OX in clinical studies in patients with SCI, wherein a dose of OX that was clinically effective in reducing FI was shown to be well tolerated and produce a 25% reduction in the number of FI episodes. RDD plans to translate the work done thus far towards clinical therapy of SCI-associated FI by carrying out critical laboratory research. This effort will define a safe and effective dosing range that will provide a rational foundation for the design of subsequent clinical studies.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710523
Entities
People
- Nir Barak
Organizations
- RDD Pharma (Israel)
- United States Army