FDA Confirms Necessity of Ventrus’ Second Phase III

As expected, the FDA will require Ventrus Biosciences (NASDAQ:VTUS) to complete a second Phase III study of diltiazem hydrochloride cream (VEN-307) before submitting a New Drug Application (NDA). Diltiazem is a calcium channel blocker often used to treat hypertension, but Ventrus is pursuing a topical formulation for the treatment of chronic anal fissures and associated pain. The second Phase III trial is enrolling and will be  completed in the fourth quarter of next year, with a NDA submission to follow before the end of 2013. Ventrus considers the new study a confirmatory measure for previous trial results; VEN-307 met both its primary and secondary endpoints in an earlier Phase III trial, improving pain on defecation and overall related pain. Because the mechanism is already used in cardiovascular indications, VEN-307 is eligible for a 505(b)(2) application, expediting the approval process by relying in part on existing safety or efficacy data. Ventrus has been preparing for a second trial since earlier in the year, so Monday’s news is little more than official confirmation from the FDA. The market may react with some negativity regardless, but VTUS should not be under pressure long-term. Read more about Ventrus Biosciences in PropThink’s previous coverage.