FDA Approves KAPIDEX for the Treatment of GERD

The U.S. Food and Drug Administration (FDA) approved KAPIDEX™ (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with Non-Erosive Reflux Disease (NERD), Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (which comes as 30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation that is designed to provide two separate releases of medication.

The approval was based on global studies conducted in 20 countries evaluating approximately 6,000 patients with erosive and non-erosive GERD.

Those studies showed:

• Two double-blind, eight-week controlled trials compared treatment with KAPIDEX to treatment with lansoprazole in patients with erosive esophagitis. KAPIDEX (60 mg) was shown to produce higher 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).

• Data from a six-month study on the maintenance of healed erosive esophagitis showed that patients treated with KAPIDEX 30 mg experienced higher overall maintenance of healed erosive esophagitis and heartburn relief versus patients who were placed on a placebo.

• In a four-week trial in patients who indicated heartburn was their primary GERD symptom, and who did not suffer from erosive esophagitis, KAPIDEX showed a greater percent of days with heartburn-free 24-hour periods over those patients given a placebo.