Ventrus Biosciences, Inc.
) recently announced positive results from its two clinical
dermal safety studies and one pharmacokinetic study on its VEN
307 (diltiazem hydrochloride 2% cream). Ventrus is developing VEN
307 for the treatment of anal fissures (AF). The encouraging
results from the AF studies positively impacted the company's
The company's dermal safety studies were single-center,
randomized, controlled trials which studied the irritation and
sensitization potential of the candidate in healthy volunteers.
The candidate was generally well tolerated and safe during the
study. Results from these studies revealed that the irritation
and sensitization potential of VEN 307 was similar to that of
placebo and saline. However, VEN 307 proved to be superior to
sodium lauryl sulfate on the same count.
Meanwhile, Ventrus' pharmacokinetic study evaluated VEN 307 in
comparison to oral diltiazem in patients suffering from AF.
Results revealed that systemic exposure of VEN 307 was around 10%
of oral diltiazem, which was consistent with previous data. All
pharmacokinetic parameters were also consistent during the study.
The study also revealed that VEN 307 maintained a high safety
margin. Ventrus stated in its press release that since diltiazem
is already approved in oral formulations for the treatment of
angina and high blood pressure, VEN 307 qualifies for the U.S.
Food and Drug Administration's 505(b) 2 registration pathway.
Ventrus is currently conducting a second pivotal trial, a phase
IIIb study (n=400), on VEN 307. The study is evaluating the
efficacy of VEN 307 in reducing severe AF-related pain during
defecation when administered three times a day for 28 days.
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 presently carries a Zacks Rank #4 (Sell). Meanwhile,
stocks such as
Biogen Idec Inc.
Gilead Sciences Inc.
) carrying a Zacks Rank #1 (Strong Buy), look more
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