NEW YORK, March 18, 2011 (GLOBE NEWSWIRE) -- Ventrus BioSciences, Inc. (Nasdaq:VTUS) has filed a revised protocol with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) with new, more robust 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, the first prescription product candidate for the treatment of hemorrhoids. Ventrus also announced that it will host a conference call on Monday, March 21 at 8:30 AM ET to discuss the proposed revised endpoints.
Russell H. Ellison, MD, Ventrus' CEO said the company is "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."
"In addition, we believe that the new endpoint definitions have the potential to provide a much stronger label which could further serve to encourage faster and broader adoption by physicians and by their patients who suffer the pain and discomfort of hemorrhoids," said Dr. Ellison. There is currently no FDA-approved prescription product for the treatment for hemorrhoids.Ventrus submitted a new SPA on March 16, 2011, 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. The SPA remains subject to FDA agreement. The pivotal Phase III clinical study for the treatment of hemorrhoids is expected to start on schedule, in mid-summer of this year. For more detailed information on the endpoints please refer to our current report on Form 8-K filed today with the Securities and Exchange Commission and our website at ventrusbio.com