Jun 20 2012
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced dosing of
the first patient in its Phase III randomized, double-blind,
placebo-controlled studies evaluating efficacy, safety and tolerability
of MuDelta (JNJ-27018966) in the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D). Furiex is conducting two simultaneous
Phase III trials, one with a 52-week treatment period and one with a
30-week treatment period, in study centers in the United States, Canada
and United Kingdom. Combined, the trials are expected to enroll
approximately 2,250 patients.
Furiex previously announced the successful completion and outcome of its
Phase II study to assess the safety and efficacy of an oral formulation
of MuDelta in patients with IBS-D. The study achieved statistically and
clinically significant results for its primary as well as a number of
key secondary endpoints, and demonstrated durable efficacy through the
12-week treatment period.
"MuDelta is a first-in-class compound and we are extremely pleased that
the Phase III trials have commenced and look forward to further
advancing the development plan for this important therapeutic
candidate," said June Almenoff, M.D., Ph.D., president and chief medical
officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, "We believe MuDelta
will fill an unmet need for an IBS-D treatment that has efficacy in both
pain and diarrhea, a good safety profile and a convenient dosing
schedule. It has the potential to create significant value as we
progress its development."
Source: Furiex Pharmaceuticals, Inc.
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