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FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
Date:1/30/2009

ng treatment option for people with GERD."

The approval was based on global studies conducted in 20 countries evaluating approximately 6,000 patients with erosive and non-erosive GERD. Two identically designed, double-blind, eight-week, randomized, controlled trials compared treatment with KAPIDEX to treatment with lansoprazole in patients with EE. KAPIDEX (60 mg) produced high overall healing rates at week eight when compared to lansoprazole 30 mg (87%, and 85%, respectively, in the first study; and 85%, and 79%, respectively, in the second study) and was generally well-tolerated.

Data from a six-month maintenance of healed EE study demonstrated that patients treated with KAPIDEX 30 mg experienced consistently high overall maintenance of healed EE and heartburn relief versus patients on placebo.

In a four-week trial in patients who identified heartburn as their primary GERD symptom and did not have esophageal erosions, KAPIDEX demonstrated a statistically significant greater percent of days (median rates) with heartburn-free 24-hour periods over placebo.

About GERD and EE

GERD affects nearly 19 million Americans and is often characterized by frequent and persistent heartburn that occurs two or more days a week despite treatment and diet changes. GERD can affect both men and women, and symptoms are often triggered by certain foods, stress or pressure on the stomach.

GERD is a chronic condition commonly known as acid reflux disease. GERD can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly. This valve opens to allow food and liquids to enter the stomach and closes to keep acid and food in the stomach.

When the LES does not close as tightly as it should, or relaxes too often, it can cause stomach contents to get into the esophagus repeatedly. The stomach is better equipped to han
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SOURCE Takeda Pharmaceuticals North America, Inc.
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