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 that 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 Phase 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™ is currently being studied in a EU Phase 3 and 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
Our primary focus is on fast-track development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders.
Safer investment and faster to market by leveraging New Therapeutic Entities (NTEs) based on approved molecules with established safety and toxicity profiles.
Molecules in development are expected to reach the market in 2 to 6 years, and occupy a lucrative niche between generics and New Chemical Entities (NCEs).
Capository™ is our proprietary and licensable delivery system for precise delivery of molecules that target conditions/diseases of the anorectal region.