Eisa: Additional Dosage and Administration of Proton Pump Inhibitor Pariet 5 mg Tablets, 10 mg Tablets Approved in Japan for ...
September 22 2017 - 3:46AM
JCN Newswire (English)
Eisai Co., Ltd. and Eisai's subsidiary for gastrointestinal
disease area EA Pharma Co., Ltd. announced today 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.
Eisai and EA Pharma consider it their mission as R&D-based
pharmaceutical companies in possession of originator drugs to seek
new value for long-listed drugs to increase patient benefits. 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, and through this, the two companies aim
to further contribute to the treatment of patients with
acid-related diseases.
About Pariet
Pariet is a proton pump inhibitor that was discovered and developed
by Eisai Co., Ltd. First launched in Japan in 1997, it is approved
in more than 100 countries and territories worldwide. In Japan,
Pariet is indicated for multiple uses, including for the treatment
of gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux
esophagitis, Zollinger-Ellison syndrome, non-erosive
gastroesophageal reflux disease, the prevention of recurrent
gastric or duodenal ulcer caused by low-dose aspirin therapy and as
an adjunctive therapy in Helicobacter pylori (H. pylori)
eradication, and is available in 5 mg, 10 mg and 20 mg tablet
formulations in Japan. In addition, in December 2010, Eisai was
granted domestic approval for additional twice-daily 10 mg and
twice-daily 20 mg dosage and administration of Pariet for treatment
of patients with reflux esophagitis who are unable to obtain
satisfactory relief with conventional proton pump inhibitor
treatment.
Details of the above approval (The underlined parts are added.)
1) Product Pariet 5 mg Tablets, Pariet 10 mg Tablets
2) Dosage and administration (Extract of the section of reflux
esophagitis only)
*The section of reflux esophagitis is divided into the parts of
<Curative Therapy> and <Maintenance Therapy>
Curative Therapy
For treatment of reflux esophagitis, the usual adult dose for oral
use is 10 mg of rabeprazole sodium administered once-daily.
However, the dosage may be increased up to 20 mg orally once-daily
depending on the severity of symptoms. The usual administration
should be restricted to up to 8 weeks. For patients who do not
achieve satisfactory therapeutic effects by proton pump inhibitors,
Pariet can be given orally at a dose of 10 mg or 20 mg twice-daily
for additional 8 weeks. The dosing at 20 mg twice-daily, however,
should be limited to those patients who have severe mucosal
injury.
Maintenance Therapy
For the maintenance therapy of reflux esophagitis showing repeated
recurrence and recrudescence, the usual adult dose for oral use is
10 mg of rabeprazole sodium once-daily. For the maintenance therapy
of reflux esophagitis in patients who do not achieve satisfactory
therapeutic effects by proton pump inhibitors, Pariet can be given
orally at a dose of 10 mg twice-daily.
About usage of Pariet for reflux esophagitis
http://www.acnnewswire.com/topimg/Low_EisaiRefluxEsophagitis.jpg
About EA Pharma
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for
gastrointestinal disease area, was established in April 2016 by
integration of the gastrointestinal business unit with at least 60
years history of the Eisai Group and the gastrointestinal business
unit of the Ajinomoto Group having amino acid as its business core.
EA Pharma is a gastrointestinal specialty pharma with a full value
chain covering R&D, logistics and sales & marketing. For
more information on EA Pharma Co., Ltd., please see
https://www.eapharma.co.jp/en/
(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.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
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