14 February 2019 - RDD Pharma announced today that the U.S. FDA granted fast track status for RDD-0315 for the treatment of faecal incontinence in spinal cord injury patients.
RDD-0315 is a topical gel containing an alpha-agonist which contracts the smooth muscle of the anal sphincter. Positive Phase 2 results evaluating the safety and efficacy of RDD-0315 for the treatment of faecal incontinence in spinal cord injury patients have previously been reported with a statistically significant reduction in the number of faecal incontinence episodes at both 8- and 12-hours post-administration.