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news.Eisai has received approval in Japan for additional twice-daily 10mg and twice-daily 20mg dosage and administration of its proton pump inhibitor Pariet (rabeprazole sodium) for the treatment of reflux esophagitis patients who are unable to obtain satisfactory relief with conventional proton pump inhibitor treatment.
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Eisai has submitted an application to the Japanese Ministry of Health, Labour and Welfare on 28 April 2010, seeking approval of additional twice-daily dosage and administration of Pariet in order to broaden the range of treatment options available to patients with refractory reflux esophagitis.
In a double-blind controlled study designed to compare once-daily and twice-daily dosing regimen healing rates as confirmed on endoscopy at week eight in reflux esophagitis patients resistant to once-daily proton pump inhibitor treatment, patients that received a twice-daily dose of Pariet Tablets 10mg or Pariet Tablets 20mg demonstrated higher healing rates as compared to those patients treated with a once-daily dose of Pariet Tablets 20mg.
In regards to safety, the study also confirmed that both Pariet 10mg and 20mg dosed twice-daily demonstrate favorable tolerability comparable to a once-daily 20mg dose.
In Japan, the drug is indicated for the treatment of stomach ulcers, duodenal ulcers, reflux esophagitis, and as an adjunctive treatment for helicobacter pylori eradication in gastric and duodenal ulcers.