Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., have announced that the FDA approved KAPIDEX(TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation designed to provide two separate releases of medication. “Through the discovery, development and commercialization of new medicines, Takeda has been a leader in acid-related therapy for more than 15 years and is committed to bringing new therapies to market,” said Alan MacKenzie, president and CEO, Takeda Pharmaceuticals North America. “KAPIDEX is a new, innovative treatment option in the well-established PPI market.” PPIs work by reducing acid production by turning off many of the acid pumps in the stomach. KAPIDEX contains two types of enteric-coated granules resulting in a concentration-time profile with two distinct peaks: the first peak occurs one to two hours after administration, followed by a second peak within four to five hours. In addition, KAPIDEX can be taken regardless of when food is consumed. “People with GERD often suffer with heartburn symptoms during the day and night,” said David Peura, MD, professor of medicine, University of Virginia Health System. “In the pivotal Phase 3 clinical studies, KAPIDEX demonstrated the ability to provide up to 24-hour heartburn relief with a side effect profile similar to lansoprazole. KAPIDEX, with its DDR formulation, is a new and exciting 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.