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Enrollment completed in study of chronic anal fissure treatment
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Researchers have completed patient enrollment in a phase 3 trial for RDD-1219 for treatment of chronic anal fissures, according to a press release issued by the manufacturer, RDD Pharma.
A randomized, double-blind study in Europe will test the efficacy and safety of two dosing regimens — once daily and twice daily — against a placebo. Patients will receive treatment for 8 weeks and have an 8-week follow up with the primary endpoint of reduced rectal pain measured by a visual analogue scale, according to the press release.
RDD Pharma estimates there are as many as 235,000 new cases of anal fissures reported in the U.S. every year, and about 40% can last months or even years.
RDD-1219 is based on nifedipine, a calcium channel blocker, and a novel, anatomically targeted drug-delivery system that the manufacturer calls “the Capository,” according to the press release.
“With only one phase 3 study required in Europe, we are looking forward to completion of the study this year and filing the [Marketing Authorization Application] in 2019,” Jason Laufer, CEO of RDD Pharma said in the press release. “RDD-1219 Capository has the potential to provide pain relief and to promote healing of this extremely painful and difficult to treat condition.” – by Alex Young
Disclosures: Laufer is employed by RDD Pharma.