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news.Ventrus BioSciences has submitted a revised protocol with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) with new, more definitions for efficacy endpoints that were recommended by the FDA in a recent meeting with the company for the first pivotal study of the company's Iferanserin (VEN 309) ointment for the treatment of hemorrhoids.
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Ventrus has submitted a new SPA that includes a revised protocol, including the newly defined endpoints, in accordance with the feedback received from that meeting, and expects a response within 45 days, which is the customary FDA review period.
Ventrus CEO Russell Ellison said they are very pleased with the new endpoint definitions in that they showed considerable differences between active drug and placebo in our analysis of an earlier Phase IIb study in Germany, which has been the cornerstone of our development program.