RDD Pharma, a leader in developing treatments for anorectal disorders, has announced that 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 recognised taht RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence.
Orphan Designation provides potential incentives from the EU such as: protocol assistance; reduced fees; funding for clinical trials; and protection from competition once the medicine is placed on the market, including 10 years of market exclusivity.
Positive Phas 2a results in evaluating the safety and efficacy of RDD-0315 have been reported with a statistically significant reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration.
An estimated 20 million adults suffer from fecal incontinence in the U.S.
About RDD-1219 and Chronic Anal Fissure: RDD-1219 Capository™ has the potential to provide pain relief and to promote healing of the extremely painful and difficult to treat condition of chronic anal fissure. There are an estimated 235,000 new cases of anal fissure reported every year in the US, and about 40% of them persist for months and even years. M.H. Madalinski. World J Gastrointestinal Pharmacology Ther 2011 April 6; 2(2): 9-16
RDD is focused on developing targeted therapeutics and delivery systems for treating diseases of the anorectal region and lower gastrointestinal tract.
In order to treat diseases in this challenging area, drugs require special formulation and delivery/application techniques to address wide variations in anatomy and physiology.
The anorectal region has unique physiological challenges including high temperature and humidity, frequent passage of stools that scrape the surface and varying absorptive capacity of the various membranes.
Because of these physiological challenges and the high cost of developing new drugs, RDD Pharma has made a strategic decision to concentrate R&D on repurposing existing approved molecules that can be brought quickly and inexpensively to market.
RDD aims to provide targeted pharmacological treatments for diseases of the anorectal region such as anal fissures, fecal incontinence and pruritus ani. Additionally, a molecule targeting radiation proctitis is in preclinical development.
Please see our Strategy page for a detailed explanation of how New Therapeutic Entities (NTEs) can repurpose existing, approved molecules to provide low cost/fast-track alternatives to the risky, cost and time-intensive pharmaceutical approval timeline.