Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence.
Last week, Ventrus announced that S.L.A. Pharma (Private), its EU partner, is ahead of schedule and has completed enrollment in the first of two pivotal Phase III studies with Diltiazem (VEN 307) for the treatment of anal fissures. Diltiazem is an off-label calcium channel blocker that is commonly used to treat anal fissures.
Although Diltiazem has been shown to be effective, it remains difficult for consumers to access. Because it is off-label, patients need to find a special pharmacy that can make it, which is a hassle for pharmacies, doctors and patients.
Ventrus hopes to resolve the situation by bringing a quality controlled, clinically trial proven product to the market. Avoiding surgery and having a prescription (ie, reimbursed) alternative is a genuine patient need.
The company’s other lead product is VEN 309, Iferanserin. This product, like VEN 307, is a topical treatment for hemorrhoids. The first Phase III trial started in August 2011 and top-line data is expected in June 2012. VEN 309 can be thought of as a prescription alternative to Preparation H, an over-the-counter cream.
Given that an increased risk of hemorrhoids is yet another consequence of leading a sedentary lifestyle, the market opportunity for a new Rx product for hemorrhoids is significant.