PARIET, A PROTON PUMP INHIBITOR,RECEIVES H. PYLORI ERADICATION INDICATION IN THE EU
(November 8, 2000) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) announced that the proton pump inhibitor PARIET (generic name: rabeprazole sodium) has received agreement for approval from all 15 EU countries for the new indication of H. pylori eradication through the Mutual Recognition Procedure. Marketing authorizations will be issued successively by each country's regulatory authorities.
This approved new indication for the treatment of peptic ulcers involves the usage of PARIET in combination with appropriate antibiotics to eradicate H. pylori. H. pylori is a bacteria that exists in the lining of the stomach and is a cause for the recurrence of gastric and duodenal ulcers. The usage of proton pump inhibitors in combination therapy with antibiotics to eradicate H. pylori has become an accepted worldwide treatment. Clinical data shows that PARIET rapidly suppresses acid production and in combination with appropriate antibiotics has a high eradication rate for H. pylori. The following dosage is recommended for seven days: PARIET 20 mg twice daily, clarithromycin 500mg twice daily, and amoxycillin 1g twice daily.
PARIET is classified as a proton pump inhibitor and demonstrates strong proton pump inhibition at the final stage of acid secretion by blocking the function of the enzyme responsible for stomach acid production. PARIET is now indicated in Europe for the treatment of symptomatic erosive or ulcerative GORD, as maintenance treatment of erosive or ulcerative GORD; for the treatment of active duodenal ulcer and active benign gastric ulcer; and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
PARIET was initially cleared for marketing in all 15 EU countries through the Mutual Recognition Procedure in September 1998, and copromotion began in the United Kingdom in September 1998, and in Germany in December 1998 with Janssen-Cilag. PARIET sales in Japan began in 1997 and in the United States, under the trade name ACIPHEX, in August 1999.