BioCentury
ARTICLE | Clinical News

Ventrus cream misses in Phase III anal fissure trial

February 13, 2014 2:33 AM UTC

Ventrus Biosciences Inc. (NASDAQ:VTUS) said thrice-daily 2% diltiazem cream ( VEN 307) missed the primary endpoint of reducing the average of worst anal pain associated with or following defecation from baseline to week four vs. placebo in a 434-patient Phase III trial to treat anal fissures. Ventrus said the efficacy of diltiazem cream was "as expected," but that the placebo effect was "greater than anticipated." In 2012, the company reported data from its first Phase III trial to treat anal fissures showing that thrice-daily 2% and 4% diltiazem cream each met the same primary endpoint vs. placebo (see BioCentury Extra, May 14, 2012).

Ventrus plans to request a pre-NDA meeting with FDA to determine next steps for diltiazem cream. Ventrus has North American rights to the topical formulation of diltiazem hydrochloride from S.L.A. Pharma AG (Liestal, Switzerland). Oral formulations of diltiazem are approved to treat angina and high blood pressure. ...