Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the US Food and Drug Administration (FDA) approved Kapidex (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 (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.

Kapidex (dexlansoprazole) delayed release capsules, previously known by the development code TAK-390MR, is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. Kapidex combines an enantiomer of lansoprazole with a Dual Delayed Release (DDR) formulation designed to provide two separate releases of medication. Kapidex, taken once-daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry.