Feb 4 An experimental drug developed by Furiex
Pharmaceuticals Inc met the main goal of a pair of
large Phase III clinical trials by significantly alleviating
diarrhea and abdominal pain associated with irritable bowel
syndrome, the company said on Tuesday.
Based on the results of the studies, Furiex said it planned
to apply by mid-year for U.S. approval of the drug, eluxadoline,
to treat diarrhea-predominant irritable bowel syndrome (IBS-d),
a debilitating bowel disorder that affects about 28 million
people in the United States and major European markets.
The company expects to seek European approval of eluxadoline
in early 2015.
"We believe that there are a lot of patients out there who
need this drug. There is a huge unmet need," Furiex Chief
Medical Officer June Almenoff said in a telephone interview.
Currently approved drugs for IBS address constipation
associated with the disorder, but there are few options for
diarrhea predominant IBS.
Furiex founder and chairman Fred Eshelman said he believes
the drug has the potential for blockbuster sales, which he
defined as annual sales of between $750 million and $1 billion.
Eluxadoline was tested at two doses against a placebo over
the course of 12 weeks to meet requirements by the U.S. Food and
Drug Administration, and for 26 weeks for European health
regulators, in Phase III studies involving 2,428 patients,
For the combined goal of improvement in abdominal pain and
stool consistency for at least half the days in the study,
eluxadoline achieved a statistically significant improvement at
the 100 milligram and 75 mg doses through 12 weeks in both
studies. On the 26-week measure, the higher dose succeeded in
both studies but the lower dose missed statistical significance
in one of the two trials, according to initial results released
by the company.
The success appeared to be driven by the percentage of
patients reporting improvements in diarrhea, which ranged from
30 percent to 37 percent versus 22 percent and 20.9 percent for
the placebo groups.
When the composite goal was broken into its two components,
researchers found a numerical improvement in pain response rates
that did not achieve statistical significance.
The drug appeared to be safe and well-tolerated in both
studies, Furiex said. The most commonly reported side effects
were constipation and nausea.
The company plans to present a far more detailed analysis of
the late stage studies at an upcoming medical meeting.
"We're very excited about the path ahead and about how this
can transform patients' lives," Almenoff said.