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Inhibitor Pariet obtained approval of additional dosage in Japan for maintenance therapy of proton pump inhibitor resistant reflux esophagitis
The above approval will add a treatment option for patients with reflux esophagitis who had inadequate response to the existing treatment by proton pump inhibitors.

TOKYO - Eisai Co., Ltd. and Eisai's subsidiary for gastrointestinal disease area EA Pharma Co., Ltd. announced that Eisai has obtained the approval of additional dosage and administration in Japan of the proton pump inhibitor Pariet 5 mg Tablets and 10 mg Tablets (generic name: rabeprazole sodium) to administer 10 mg of rabeprazole sodium per dose twice-daily for the maintenance therapy of proton pump inhibitor-resistant reflux esophagitis (reflux esophagitis in which it is difficult to achieve satisfactory therapeutic effects by existing treatment with once-daily dosing of proton pump inhibitors).

In Japan, Eisai is the marketing and manufacturing authorization holder for Pariet, while EA Pharma is responsible for distribution.

Reflux esophagitis is a condition which causes erosion of the mucosal lining of the esophagus due to the regurgitation of stomach acid and other causes, as well as frequent and persistent symptoms such as heartburn, discomfort in the throat and belching, with repeated recurrence and recrudescence. The prevalence of this condition in Japan is estimated to be 10%.(1)

In many cases, 8 weeks of initial treatment followed by maintenance therapy with a once-daily proton pump inhibitor is sufficient to cure reflux esophagitis and prevent remission. However, in approximately 15% of reflux esophagitis cases, these treatments are not enough to achieve satisfactory therapeutic effects.(2)

For patients with proton pump inhibitor-resistant reflux esophagitis, Pariet is the only proton pump inhibitor available for treatment by twice-daily dosing at 10 mg or 20 mg each. However, there is an 8 week dosing period limit, and after that, maintenance therapy by once-daily dosing at 10 mg occurs. With the above approval, Pariet becomes the only proton pump inhibitor available for maintenance therapy by twice-daily dosing at 10 mg and is anticipated to further fulfil unmet medical needs.

The above approval was made based on the results of a double-blind controlled Phase III clinical study conducted in Japan, in which the efficacy and safety of twice-daily dosing of Pariet 10 mg Tablets were evaluated against once-daily dosing of Pariet 10 mg Tablets in patients with reflux esophagitis who had inadequate response to existing treatment with proton pump inhibitors.

In the primary endpoint of non-recurrence rates as confirmed by endoscopy at 52 weeks of maintenance therapy, the twice-daily dosing group demonstrated a statistically significant improvement over the once-daily group, with non-recurrence rate in the twice-daily dosing group at 73.9% compared to 44.8% in the once-daily group (P<0.001). Adverse drug reactions (at least 2 incidences) observed in the above study were diarrhea, increased blood pressure and increased blood thyroid stimulating hormone, which is consistent with the known safety profile of Pariet.

The above approval will add a treatment option for patients with reflux esophagitis who had inadequate response to the existing treatment by proton pump inhibitors.

Source: Eisai Co., Ltd.
  1. Japanese Society of Gastroenterology, GERD Diagnosis Guidelines, 2015 (2nd Revised Edition)
  2. Chiba N., et al, Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis, Gastroenterology. 1997;112(6):1798-810.
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January:
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