Dexlansoprazole Modified Release

Abstract

Dexlansoprazole modified release (dexlansoprazole MR) is an orally administered delayed-release formulation of the R-enantiomer of the proton pump inhibitor lansoprazole that is effective in improving the healing of all grades of erosive oesophagitis, maintaining the healing of erosive oesophagitis and in the treatment of symptomatic non-erosive reflux disease (NERD). In two large, identical, 8-week, randomized, double-blind, multicentre phase III trials, dexlansoprazole MR 60 mg once daily achieved complete healing in >or=92% of patients with all grades of erosive oesophagitis (primary endpoint) and was noninferior to lansoprazole 30 mg once daily using life-table analysis. Moreover, in a randomized, double-blind, multicentre phase III trial in patients with healed erosive oesophagitis, dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing following 6 months' treatment (primary endpoint). In addition, the proportion of 24-hour heartburn-free days (primary endpoint) was significantly greater in recipients of dexlansoprazole MR 30 mg once daily than in recipients of placebo following 4 weeks' treatment in a large, randomized, double-blind, multicentre phase III trial in patients with NERD. Dexlansoprazole MR 30 or 60 mg once daily was generally well tolerated in a pooled analysis of clinical trials of up to 12 months' duration.