Ventrus BioSciences (VTUS) Announces Improved, FDA-Recommended Endpoints Proposed for Phase III Hemorrhoid Study

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.

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.

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