The US Food and Drug Administration (FDA) has granted Fast Track status for RDD-0315, formulated for the treatment of fecal incontinence in spinal cord injury patients, RDD Pharma reports in a news release.
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,” says Dr Nir Barak, chief medical officer and dounder of RDD Pharma.
“We are pleased to have the first clinical trial of RDD-0315 ongoing in the US 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, according to the release.
[Source(s): RDD Pharma, PR Newswire]
