RDD Pharma, Inc., a specialty pharmaceutical company focused on development and commercialization of innovative therapeutics for anorectal and lower gastrointestinal disorders, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track status for RDD-0315 for the treatment of fecal incontinence in spinal cord injury patients. Fast track is a designation by the FDA for an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
Receiving Fast Track designation for RDD-0315 is indicative of the high unmet need that currently exists for the nearly 300,000 individuals with spinal cord injury, the majority of which as a result also suffer from fecal incontinence, which significantly impacts morbidity, mortality and quality of life. We are pleased to have the first clinical trial of RDD-0315 ongoing in the U.S. and look forward to initiating a Phase 2b study later in the year. We believe RDD-0315 has the opportunity to be the first drug treatment option for patients with spinal cord injury and associated fecal incontinence
said Dr. Nir Barak,
Chief Medical Officer
and Founder of RDD Pharma.
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 fecal incontinence in spinal cord injury patients have previously been reported with a statistically significant reduction in the number of fecal incontinence episodes at both 8- and 12-hours post-administration.