Diltiazem cream (VEN 307)
A topical treatment for the relief of pain associated with anal fissures.
Anal fissures are small tears or cuts in the skin that lines the anus. They can be extremely painful, cause bleeding and often require surgery, which itself can have unsatisfactory outcomes. We estimate that there are currently up to 4.3 million cases in the U.S. At present, we are not aware of any FDA-approved drugs for the treatment of pain associated with anal fissures. Diltiazem cream, however, is currently used as the preferred treatment by many gastroenterologists across the U.S. in a version that must be specially mixed, or compounded, for each patient in the pharmacy. When applied topically for the treatment of anal fissures, diltiazem, a drug that has been used for decades for hypertension and angina, dilates the blood vessels supplying the region, reduces anal sphincter tone, and thereby substantially decreases pain. In the majority of multiple clinical trials conducted against placebo or topical nitroglycerin, another commonly used but not FDA-approved treatment, topical nitroglycerin, diltiazem cream significantly reduced the pain associated with anal fissures. Applied topically in our proprietary formulation, diltiazem yields lower blood levels, at less than one-tenth the amount of the lowest dose used for cardiovascular treatment and yet has a considerably greater effect on sphincter tone than diltiazem taken orally. If VEN 307 is approved, we believe we have the potential to capture immediate market share due to the familiarity of gastroenterologists with the current use of diltiazem to treat anal fissures, and its ease of prescription as a pre-formulated FDA-approved product, with no need for compounding necessary at the pharmacy. We have licensed the exclusive North American rights to VEN 307 for the topical treatment of anal fissures from S.L.A. Pharma AG, who began a Phase III clinical trial in the E.U. in November 2010.
Phenylephrine gel (VEN 308)
For the treatment of fecal incontinence associated with ileal pouch anal anastomosis, or IPAA, an FDA orphan indication.
Ileal pouch anal anastomosis is a surgical procedure used as part of a colectomy, which is a treatment for patients with ulcerative colitis. Fecal incontinence resulting from dysfunctional sphincter tone is a common consequence of this procedure. We estimate that approximately seven million people currently suffer from fecal incontinence. We are not aware of any FDA-approved drugs for fecal incontinence. Currently, there are few options available to treat this disorder. Phenylephrine has been used by millions of patients as a common ingredient of cough and cold medications. Topical phenylephrine significantly (and in some patients, dramatically) improved patient bowel control. In multiple clinical trials with patients suffering from IPAA associated fecal incontinence. Applied topically, phenylephrine gel increases anal sphincter tone, thereby improving fecal incontinence in patients where sphincter tone is the major cause of their symptoms (such as in the case of post-IPAA surgery). We have licensed the exclusive North American rights for VEN 308 as a topical treatment for fecal incontinence from S.L.A Pharma.