TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive E... (tes for patients with EE. In onestudy th...)

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TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis

Date:5/18/2008

tes for patients with EE. In one study, the life table analysis showed that 93 percent and 95 percent of TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experienced healing versus 85 percent of lansoprazole 30 mg patients.

In a second study, the life table analysis demonstrated that 92 percent of both 60 mg and 90 mg patients experienced healing versus 86 percent of patients on lansoprazole 30 mg. The crude rate evaluation showed that 85 percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg, respectively) experienced healing versus 79 percent of patients taking lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically significantly higher than lansoprazole 30 mg in both studies using crude rate analysis.

The most frequent treatment-related adverse event (AE) for patients in the combined healing studies was diarrhea, which occurred in similar rates across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent for lansoprazole 30 mg).

"Findings from both studies demonstrated that patients taking TAK-390MR 60 mg and 90 mg showed numerically higher overall healing than those taking lansoprazole with a similar rate of AEs across groups," said Dr. Prateek Sharma, professor of medicine, gastroenterology section, University of Kansas School of Medicine.

Maintenance of Healed Erosive Esophagitis

TAK-390MR was compared to placebo in a double-blind, randomized, controlled trial in patients with confirmed healing of EE. A total of 445 patients were enrolled in the global, six-month study. The primary objective was to evaluate the overall maintenance rate of healed EE after once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objective was to evaluate the frequency of heartburn over the six-month study
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