Eisai has filed an application for the proton pump inhibitor Pariet in Japan looking for a further indication expansion for use in the prevention of recurrent gastric or duodenal ulcer caused by low-dose aspirin therapy as well as the approval of a new 5mg tablet formulation.
The application is based on results of a double-blind comparative Phase II/III trial conducted in 472 patients who required long-term administration of low-dose aspirin and who were confirmed to also have a history of gastric or duodenal ulcer.
The data from the trial demonstrated reduction in the cumulative incidence of recurrent gastric or duodenal ulcer among the patient groups administered 5mg and 10mg of rabeprazole, respectively, when compared to a comparator, thereby showing the superiority of rabeprazole in preventing ulcer recurrence.
In addition, adverse events (AEs) in the trial were consistent with the known safety profile of rabeprazole and no new or unexpected AEs occurred.
Initially, Pariet was launched in Japan in 1997 and is currently approved in more than 100 countries and territories worldwide.
The drug is indicated for multiple uses, including the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, non-erosive gastroesophageal reflux disease.
It is also indicated as an adjunct therapy in several types of Helicobacter pylori (H. pylori) eradication, including in patients with gastric ulcer, duodenal ulcer, or H. pylori gastritis.
The company said that by expanding the existing indications for Pariet and receiving approval for the new 5mg tablet formulation, it aims to increase the clinical value of the drug so as to further contribute to the range of treatment options available to patients with acid-related diseases.
