The Food and Drug Administration (FDA) has granted Fast Track designation to RDD-0315, a novel topical gel for the treatment of fecal incontinence in spinal cord injury patients.

RDD-0315 contains the alpha-agonist oxymetazoline in a topical gel formulation; it works by contracting the internal anal sphincter muscle. In a randomized, controlled crossover study involving 19 patients with spinal cord injury, the investigational gel was found to be beneficial, due to the local effect of oxymetazoline; a statistically significant reduction in the number of fecal incontinence episodes was observed 8 hours and 12 hours post-administration. 

“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,” said Dr Nir Barak, CMO of RDD Pharma. “We believe RDD-0315 has the opportunity to be the first drug treatment option for patients with spinal cord injury and associated fecal incontinence.”

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