RDD Pharma, a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders, have completed enrollment in the pivotal phase 3 study in Europe of RDD-1219 for the treatment of chronic anal fissure.
In December 2017, an independent data monitoring committee reported no safety concerns and confirmed the company’s statistical assumptions, recommending that no further enrollment was required.
“With only one phase 3 study required in Europe, we are looking forward to completion of the study this year and filing the MAA in 2019,” said Jason Laufer, chief executive officer 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.”
The randomized, double-blind, placebo-controlled multi-site phase 3 trial, conducted in Europe, is evaluating the efficacy and safety of two dosing regimens – once daily or twice daily. Patients are treated for 8 weeks with an 8-week follow-up period. The primary endpoint is rectal pain reduction assessed via a visual analogue scale (VAS).