WebMD Medical News
Louise Chang, MD
Feb. 6, 2009 -- The FDA has approved Kapidex delayed-release capsules as a
once-daily treatment for gastroesophageal reflux disease (GERD) and for erosive
esophagitis, which is GERD-related damage to the esophagus.
Kapidex, which is taken orally, belongs to a class of drugs called proton
pump inhibitors. It's the first proton pump inhibitor with a dual delayed
release formulation, which provides two separate releases of medication,
according to Takeda Pharmaceutical Company, which makes Kapidex.
In a news release, Takeda says that the FDA approved Kapidex based on global
studies of about 6,000 GERD patients, some of whom had erosive esophagitis. In
those studies, Kapidex trumped a placebo at treating heartburn. Among erosive
esophagitis patients studied, those taking Kapidex also showed high healing
rates of erosive esophagitis that were comparable to erosive
esophagitis healing rates among patients taking Prevacid, another proton
pump inhibitor made by Takeda.
Takeda reports that the most commonly reported adverse reactions with
Kapidex included diarrhea, abdominal pain, nausea, upper respiratory tract
infection, vomiting, and flatulence.
SOURCES:News release, Takeda Pharmaceuticals North America.FDA: "Drug Details: Kapidex."
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