RDD Pharma Receives Fast Track Designation from FDA for RDD-0315 for Treatment of Fecal Incontinence in Spinal Cord Injury Patients
NEW YORK, Feb. 14, 2019 /PRNewswire/ -- RDD Pharma, Inc., a specialty pharmaceutical company focused on development and commercialization of innovative therapeutics for anorectal and lower gastrointestinal disorders, announced today 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," said Dr. Nir Barak, Chief Medical Officer and Founder of RDD Pharma. "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."
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.
About RDD Pharma
RDD Pharma is a privately held specialty pharma company focused on development and commercialization of innovative therapeutics for anorectal diseases and lower-gastrointestinal tract disorders. The company has two clinical stage products which serve significant unmet needs. RDD-0315 is currently in Phase 2 development for the treatment of fecal incontinence in spinal cord injury patients. RDD-0315 has received Orphan Drug status in the E.U. and Fast Track designation in the U.S. RDD-1609 is being developed for the treatment of Pruritus Ani. Symptoms range from mild to intense and can last for a significant duration of time in some patients, and depression can result when the condition is severe and persistent. RDD Pharma is also exploring other potential therapies for anorectal and lower gastrointestinal disorders for future clinical development. For more information, please visit www.rddpharma.com.
This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Spinal Cord Injury Research Program under Award No. W81XWH-17-1-0523. The U. S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. Opinions, interpretations, conclusions and recommendations are those of RDD Pharma and are not necessarily endorsed by the Department of Defense.
Executive Vice President, Global Operations
RDD Pharma, Ltd.
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SOURCE RDD Pharma