Japan-based Takeda Pharma -ceutical's wholly-owned subsidiary, Takeda Pharma -ceuticals North America, has received approval from the US Food and Drug Administration (FDA) for Kapidex (dexlansoprazole), a once-daily delayed release capsules.
This drug is used for the oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing and maintenance of erosive esophagitis (EE). Kapidex (30 mg and 60 mg) is said to be 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 Mr Alan MacKenzie, CEO, Takeda Pharmaceuticals North America. "Kapidex is a new, innovative treatment option in the well-established PPI market."
According to the company, PPIs work by reducing acid production by turning off many of the acid pumps in the stomach. Kapidex is said to contain 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 Mr David Peura, Professor of medicine, University of Virginia Health System. "In the pivotal phase III clinical studies, Kapidex demonstrated the ability to provide up to 24-hour heartburn relief with a side effect profile similar to lansoprazole. Takeda's drug, with its DDR formulation, is a new and exciting treatment option for people with GERD."
The approval is supoosed to be 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)is said to have produced high overall healing rates at week eight when compared to lansoprazole 30 mg (87 percent, and 85 percent, respectively, in the first study; and 85 percent, and 79 percent, respectively, in the second study) and was generally well-tolerated.
According to the company, 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.