Ventrus Biosciences, Inc.
) focuses on developing and commercializing drugs for
gastrointestinal treatments. The company's lead candidate, VEN
307 (diltiazem hydrochloride 2% cream), is being developed for
the treatment of anal fissures (AF).
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Earlier in the week Ventrus completed patient enrollment and
randomization of a phase III study (n= 434) on VEN 307. This is
Ventrus' second pivotal phase III study on VEN 307. The study,
enrolment for which started in Oct 2012, is being conducted at 90
global clinical sites.
The randomized, double-blind, placebo-controlled,
parallel-treatment group, multicenter study is evaluating the
efficacy of VEN 307 in reducing severe AF-related pain during
defecation when administered three times a day for 4 weeks.
Ventrus is also evaluating the effects of VEN 307 in bringing
down the daily overall AF-related pain. Patient global impression
of improvement at the 29th day is also being evaluated.
Results from the study are expected in the first quarter of 2014.
Ventrus intends to seek U.S. approval for the candidate in the
following quarter (in the event of positive results from the
Ventrus successfully completed the first pivotal phase III study
(n=465) on VEN 307 in May last year. Results from the study
revealed significant improvements in average worst anal pain
associated with or following defecation in patients under VEN 307
compared to placebo. An improvement in overall
anal-fissure-related pain was also observed.
We note that diltiazem's oral formulations are already approved
for the treatment of angina and high blood pressure. As a result,
VEN 307 is qualified for the FDA's 505(b)2 registration pathway.
Ventrus also has VEN 308 in its pipeline. The candidate is being
developed for the treatment of fecal incontinence. We expect
investor focus to remain on the company's pipeline.
Ventrus presently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
Lannett Company, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).