RDD Pharma, a specialty pharmaceutical company, has started dosing patients in its Phase lll clinical trial of RDD-1219 for the topical treatment of chronic anal fissure.
Chronic anal fissure is a painful condition caused by a tear in the anal canal that does not heal.
An estimated 235,000 new cases of anal fissure are currently reported every year in the US, and nearly 40% of them continue for months, sometimes years.
The trial is presently being conducted in Europe, the randomised, double-blind, placebo-controlled multi-site Phase lll trial will assess the efficacy and safety of two dosing routines (once daily or twice daily).
Nearly 470 patients are expected to be enrolled in the study.
RDD Pharma CEO Jason Laufer said: "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.
"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, which is easy to administer and without systemic side effects."
The company has also another clinical stage product RDD-0315 for fecal incontinence, an indication for which there are currently no approved products.