NEW YORK, May 18, 2016 /PRNewswire/ -- RDD Pharma, a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders, announced today that the first patient has been dosed in its Phase 3 clinical trial of RDD-1219 for the topical treatment of chronic anal fissure.
"Dosing the first patient in our Phase 3 program is an important milestone for RDD Pharma in the development of our lead product candidate," said Jason Laufer, CEO of RDD Pharma. "RDD 1219 Capository™ has the potential to provide pain relief and to promote healing of this extremely painful and difficult to treat condition. We are now focused on successfully executing this trial, which is designed to establish a clear path to approval in major global markets."
"Current therapeutic options for anal fissure are limited: they can be challenging for patients to administer and are associated with systemic side effects," continued Mr. Laufer. "RDD 1219 is based on a calcium channel blocker and a novel, anatomically targeted drug-delivery system that has the potential to provide effective treatment that is easy to administer and without systemic side effects."
The randomized, double-blind, placebo-controlled multi-site Phase 3 trial is being conducted in Europe, and will evaluate the efficacy and safety of two dosing regimens (once daily or twice daily).
RDD plans on enrolling approximately 470 patients in this pivotal EU study.
About RDD Pharma
RDD is a privately held specialty pharma company, backed by Orbimed. RDD focuses on fast-track development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders. The company has two clinical stage products which serve significant unmet needs: (1) RDD-1219 for chronic anal fissure and (2) RDD-0315 for fecal incontinence, an indication for which there are no approved Rx products.
About Chronic Anal Fissure
Chronic anal fissure is a painful condition caused by a tear in the anal canal that does not heal. 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.
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SOURCE RDD Pharma