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°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received approval of a new indication for proton pump inhibitor Pariet® Tablets 10 mg (rabeprazole sodium, “Pariet”) in Japan for use in the prevention of recurrent gastric or duodenal ulcers caused by low-dose aspirin therapy. In addition, Eisai has also received approval of a 5 mg tablet formulation with the same indication as Pariet Tablets 10 mg.

In recent years, the aging of Japan's population has led to an increase in the number of patients requiring long-term low-dose aspirin therapy to prevent recurrent thrombotic events in the heart or brain. At the same time, however, low-dose aspirin administration is also associated with the development of mucosal injuries in the upper gastrointestinal tract. As it is often difficult to discontinue low-dose aspirin administration in patients, it is therefore important from a clinical standpoint to work to prevent mucosal injuries from developing in the upper gastrointestinal tract while continuing to administer treatment to prevent cardiovascular and cerebrovascular events.

The data used in the application was from a Phase Ⅱ/Ⅲ study (Study 308 / Study 309) on patients who required long-term administration of low-dose aspirin and who were confirmed to also have a history of gastric or duodenal ulcers. The results of Study 308 showed that cumulative recurrence rates of gastric or duodenal ulcers over 24 weeks (the study's primary endpoint) in the 5 mg and 10 mg Pariet groups were 2.8% and 1.4%, respectively, compared to 21.7% for the comparator group (teprenone). Thus, both Pariet groups demonstrated a significantly better preventative effect than the comparator group (p<0.001 for both Pariet groups vs. the comparator group)¹. Furthermore, in Study 309 which examined the long term administration of Pariet 5 mg and 10 mg for a maximum of 52 weeks after initial treatment of 24 weeks, both dosage groups maintained a preventative effect over the whole 76 week maximum treatment period. The most commonly reported side effects (5 or more cases observed) in both Study 308 and 309 were diarrhea and constipation, and this was consistent with the known safety profile of Pariet. In addition, the registration validity period for this indication for Pariet is 4 years.

Currently approved in more than 100 countries and territories worldwide, Pariet was first launched in Japan in 1997, where it is indicated for multiple uses, including for the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, non-erosive gastroesophageal reflux disease, and as an adjunct therapy in various types of Helicobacter pylori (H. pylori) eradication, including in patients with gastric ulcer, duodenal ulcer, or H. pylori gastritis.

By gaining this approval, Eisai 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.

Pariet is a proton pump inhibitor (PPI) that was discovered and developed by Eisai. First launched in Japan in 1997, it is approved in more than 100 countries and territories worldwide. In Japan, Pariet is available in 10 mg and 20 mg tablet formulations and is indicated for multiple uses, including for the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, non-erosive gastroesophageal reflux disease, and as an adjunctive therapy in various types of Helicobacter pylori (H. pylori) eradication, including in patients with gastric ulcer, duodenal ulcer, or H. pylori gastritis. In addition, in December 2010, Eisai was granted domestic approval for additional dosage and administration for Pariet as twice-daily 10 mg and twice-daily 20 mg treatment regimens for patients with reflux esophagitis who are unable to obtain satisfactory relief with conventional PPI treatment. Most recently, Eisai received marketing authorization in Japan in August 2013 for two types of triple formulation packs (combination packs) for H. pylori eradication, both of which contain Pariet Tablets 10 mg, and in February 2014 launched the products Rabecure® Pack 400 and Rabecure Pack 800 for use in primary H. pylori eradication, as well as Rabefine® Pack for use in secondary H. pylori eradication. Among the most commonly reported adverse reactions are rash, constipation, diarrhea, and headache.
Eisai is also conducting a Phase Ⅲ study in Japan on Pariet as a maintenance therapy for patients with reflux esophagitis resistant to PPI treatment.