Ventrus Adds Third Treatment Arm of Shorter Treatment Duration to Its Phase III Study of Iferanserin in Hemorrhoids
In its response, the
"When we analyzed our Phase IIB German study that compared Iferanserin given twice daily for 14 days, with placebo, using these endpoints, we observed that the majority of Iferanserin treated patients started their response by Day 3. This raises the possibility that Iferanserin therapy may require a shorter duration of treatment to show adequate efficacy to stop the bleeding, itching and pain associated with hemorrhoids," said
Following the feedback from the
Arm 1: placebo ointment twice daily intra-anally for 2 weeks;
Arm 2: Iferanserin ointment twice daily for 2 weeks; and
Arm 3: Iferanserin ointment twice daily for 1 week followed by placebo ointment twice daily for 1 week.
In its response to the SPA submission the
"We will go forward with the
About Iferanserin (VEN 309)
Iferanserin (VEN 309) is a new chemical entity, or NCE, for the topical treatment of hemorrhoids, which targets a specific serotonin receptor (5HT2A) thought to be important in the disease. The first late phase clinical trial (Phase III) with Iferanserin is expected to start in the summer of 2011 and we expect data to be available in the first quarter of 2012.
Ventrus is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders. Our lead product is Iferanserin (VEN 309) for the topical treatment of hemorrhoids. Our additional product candidate portfolio consists of two in-licensed late-stage drugs intended to treat anal fissures (VEN 307) and fecal incontinence (VEN 308). The first Phase III clinical trial with VEN 307 has begun in
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Ventrus Biosciences, Inc. David Barrett646-706-5208 firstname.lastname@example.org
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