FDA approves Actavis,
Valeant drugs for irritable bowel syndrome
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[May 28, 2015] By
Toni Clarke
WASHINGTON (Reuters) - U.S. health
regulators approved new irritable bowel syndrome drugs from Actavis Plc
and Valeant Pharmaceuticals International Inc on Wednesday, validating
big investments both companies made to acquire the products.
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The Food and Drug Administration approved eluxadoline, to be sold
under the brand name Viberzi, which Actavis obtained with its $1.1
billion acquisition last year of Furiex Pharmaceuticals.
The agency also approved Valeant's Xifaxan, also known as rifaximin,
which the company acquired with its $11 billion purchase earlier
this year of Salix Pharmaceuticals Ltd.
Both drugs are designed to treat diarrhea-predominant irritable
bowel syndrome (IBS-D), a condition that affects about 28 million
people in the United States and Europe and can cause abdominal pain,
bloating and diarrhea.
Analysts expect Viberzi to generate U.S. sales of about $450 million
by 2020 according to Thomson Reuters data. They expect Xifaxan sales
for IBS-D to top $1 billion.
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The two drugs work differently. Xifaxan is an antibiotic that was
approved in 2004 to treat traveler's diarrhea. It was approved in
2010 to reduce the risk of hepatic encephalopathy, or brain
abnormalities associated with liver disorders.
Viberzi is known as a combination mu opioid receptor agonist and
delta opioid receptor antagonist. It is designed to treat IBS-D
while reducing the risk of constipation that can occur with other mu
opioid receptor agonists, such as the anti-diarrhea drug Imodium.
"For some people, IBS can be quite disabling, and no one medication
works for all patients suffering from this gastrointestinal
disorder," Dr. Julie Beitz, director of the FDA office in charge of
the review, said in a statement.
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The most common side effects of Xifaxan include nausea and raised
liver enzymes, the FDA said. It said caution should be used when
prescribing the drug for patients with severe liver impairment or
when combined with certain other drugs.
The most serious side effect of Viberzi is the risk of inflammation
of the pancreas known as pancreatitis. It should not be used in
patients with a history of bile duct obstruction, pancreatitis,
severe liver impairment or severe constipation, or in patients who
drink more than three alcoholic drinks a day, the FDA said.
Several cases of pancreatitis cropped up in early clinical trials of
Viberzi. After that, Furiex altered the criteria for entry into the
trials and excluded patients at risk of the condition. As a result,
some 55 percent of screened patients were not eligible for the
trial.
(Reporting by Toni Clarke; Editing by Sandra Maler and David
Gregorio)
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