Vonoprazan fumarate: Phase III data

A double-blind, Japanese Phase III trial in 621 patients with a history of gastric or duodenal ulcers who require long-term low-dose aspirin showed that once-daily 10 and 20 mg oral TAK-438 each met the primary endpoint of non-inferiority to once-daily 15 mg lansoprazole in the proportion of patients with endoscopically confirmed recurrent peptic ulcers at week 24 (0.5% and 1.5%, respectively, vs. 2.8%, p<0.0001 for non-inferiority for both). Additionally, a significantly smaller proportion of patients receiving low- and high-dose TAK-438 developed hemorrhagic lesion in the stomach or duodenum through week 24 vs. lansoprazole (0% for both doses of TAK-438 vs. 2.9%, p=0.0129 for both). Furthermore, the cumulative incidences of gastric or duodenal ulcers or hemorrhagic lesion at week 24 was significantly lower in both TAK-438 arms compared to lansoprazole (p=0.0066 and p=0.0471, respectively). The most common treatment-emergent adverse event reported was nasopharyngitis. The data were presented at the Digestive Disease Week meeting in Chicago and were included in an NDA that Takeda submitted in Japan for TAK-438 to treat acid-related diseases in February. Takeda said it expects a response in Japan by the end of 1Q15, but declined to disclose plans for regulatory submissions in other countries. ...