Ventrus Biosciences Receives Date for Type B pre-NDA Meeting with FDA for DOLIZEM (Diltiazem Hydrochloride Cream) in Anal Fissures

Ventrus Biosciences Receives Date for Type B pre-NDA Meeting

with FDA for DOLIZEM (Diltiazem Hydrochloride Cream) in Anal Fissures

NEW YORK, April 4, 2014 (GLOBE NEWSWIRE) -- Ventrus Biosciences,

Inc. (Nasdaq: VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced

that, in response to a request from the company, the U.S. Food and Drug Administration (FDA) has scheduled a Type B pre-NDA meeting

on Thursday, June 19, 2014 at which the company will seek guidance on its planned new drug application (NDA) for DOLIZEM (diltiazem

hydrochloride cream) in anal fissures. Ventrus would expect to file an NDA in the second half of 2014 with an anticipated PDUFA

date in the second half of 2015 if there is a positive outcome of this pre-NDA meeting.

About DOLIZEM (Diltiazem Hydrochloride Cream)

Diltiazem hydrochloride is a calcium-channel blocker that has

been marketed in oral formulations for the treatment of angina and high blood pressure for over two decades. Diltiazem hydrochloride

cream is applied perianally to treat pain related to anal fissure. It has been shown to normalize internal anal sphincter pressure

and reduce anal maximal resting pressure, or MRP, and its vasodilator activity has the potential to improve blood supply, thereby

decreasing the pain associated with anal fissures.

Anal fissure is a tear in the lining of the anal canal characterized

by severe anal pain associated with or after bowel movements. It is a common anal disorder which is believed to be underdiagnosed.

The pathogenesis of anal fissure is hypothesized to be initiated by the passage of a hard fecal bolus, resulting in a split in

the epithelium of the anal canal. Along with poor vascular supply of the anal epithelium, increased activity (tone) of the internal

anal sphincter smooth muscle further compromises the anodermal blood supply and contributes to the pain and ischemia of the anal

epithelium, perpetuating ulceration and preventing healing.

In 2010, it was estimated by SDI Health LLC that there were

approximately 1.1 million office visits per year for anal fissures. Topical diltiazem, which is not approved by the FDA as a use

for anal fissure, is currently listed in the U.S. anal fissure treatment guidelines as a preferred agent prior to attempting surgery,

and is available only as a compounded medicine.

Ventrus is a specialty pharmaceutical company primarily focused

on the development and commercialization of prescription drugs addressing gastrointestinal problems. The Company's lead product

is DOLIZEM for the treatment of anal fissures. The Company has also recently licensed intellectual property and know-how relating

to the oral delivery of bacteria, viruses and drugs to specific sites in the intestine, using a pH sensitive controlled release

platform technology. The potential indication areas include (i) gastro-intestinal, auto-immune and metabolic disorders, (ii) viral

and bacterial vaccines, and (iii) optimized colonic delivery of drugs.

Please Note: The information provided herein contains estimates

and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and

uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among

others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates;

the unpredictability of the clinical development of our product candidates and of the duration and results of regulatory review

of those candidates by the FDA and foreign regulatory authorities; our reliance on our lead product candidate, VEN 307; the unpredictability

of the size of the markets for, and market acceptance of, any of our products; our anticipated capital expenditures, our estimates

regarding our capital requirements, and our need for future capital; our ability to retain and hire necessary employees and to

staff our operations appropriately; and the possible impairment of, or inability to obtain, intellectual property rights and the

costs of obtaining such rights from third parties. The reader is referred to the documents that we file from time to time with

the Securities and Exchange Commission.

Source: Ventrus Biosciences