FDA OKs New GERD Drug Kapidex

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.