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news.Takeda Pharmaceuticals North America has announced combined results from two Phase III studies which showed that TAK-390MR resulted in higher healing rates than lansoprazole among patients with more severe grades of erosive esophagitis.
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As part of the Phase III clinical trials, 4,092 patients were assessed for overall erosive esophagitis (EE) healing at week eight in two identically designed trials. Patients were randomized to receive 60mg or 90mg of TAK-390MR or 30mg of lansoprazole. A retrospective, integrated analysis showed the difference in healing rates, or therapeutic gains, between 60mg and 90mg of TAK-390MR and 30mg of lansoprazole, increased as the severity of EE increased.
Therapeutic gains were greatest in patients with the most severe grade of EE (grade D) – 12% for 60mg (n=74) and 20% for 90mg (n=83) of TAK-390MR. There were no significant differences in adverse events observed between the treatment groups.
Stuart Atkinson, vice president of clinical science at Takeda, said: “The development of TAK-390MR is another example of Takeda’s commitment to patients who suffer from gastroesophageal reflux disease and erosive esophagitis. TAK-390MR has the potential to serve as an important new treatment option for physicians and patients. If approved, it would be the first proton pump inhibitor that employs a dual delayed release formulation, delivering medication in two separate releases.”