Topical Gel Gets Fast-Tracked for Fecal Incontinence in Spinal Cord Injury Patients

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. Read more.

Source: MPR, February 15, 2019

RDD Pharma Awarded CDMRP Grant for Clinical Drug for SCI Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application. The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK. “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma. “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.” Read more.

Source: PRNewswire, September 14, 2017

RDD Pharma Receives Orphan Designation for RDD-0315 in Spinal Cord Injury Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency’s Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury. The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence. “We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma. ‘We have the potential to positively impact the health, well-being and quality of life in this patient population. ‘ Read more.

Source: PRNewswire, July 5, 2017