(Corrects stock's Tuesday close in last paragraph to $4.38 from
Feb 12 Ventrus Biosciences Inc said its
lead experimental drug to treat anal fissures failed to reduce
pain more than a placebo in a late-stage trial, sending its
shares plunging 67 percent in premarket trading.
In May 2012, the company had shown the treatment, codenamed
VEN 307, was superior to a dummy drug for the same indication,
in another late-stage trial.
Ventrus said on Wednesday that gastrointestinal disorders
were the most common adverse events reported by the 434 patients
in the study, which aimed to reduce anal pain associated with or
An anal fissure is a tear in the lining of the anal canal
characterized by severe pain associated with or after bowel
Ventrus acquired the North American rights to VEN 307, also
known as Diltiazem Hydrochloride 2% Cream, for the treatment of
anal fissures from S.L.A. Pharma AG.
The drug, which has been used for decades to treat angina
and hypertension, dilates the blood vessels supplying the
region, substantially decreasing pain.
VEN 307, which is not approved to treat anal fissures, is
currently listed in the U.S. anal fissure treatment guidelines
as a preferred agent prior to attempting surgery, and is
available only as a compounded medicine, the company said.
"While this second study confirms a consistent effect in
decreasing (anal fissure) AF-related pain with Diltiazem 2%,
results among placebo patients are inconsistent across these two
pivotal studies", said Chief Executive Russell Ellison.
Ventrus plans to request a meeting with the U.S. Food and
Drug Administration to determine the next steps in the path
towards submitting a new drug application for the cream.
The New York-based company's shares were down at $1.41 in
trading before the bell. They closed at $4.38 on the Nasdaq on
(Reporting by Natalie Grover in Bangalore; Editing by Savio