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ACIPHEX® (rabeprazole sodium) Approved For Treatment Of Symptomatic Gastroesophageal Reflux Disease (GERD)
Proton Pump Inhibitor (PPI) Approved for Daytime and Nighttime Heartburn Relief
Teaneck, NJ and Titusville, NJ (February 15, 2002) -- Eisai Inc. and Janssen Pharmaceutica Inc. announced today that the U.S. Food and Drug Administration has approved the expanded use of the PPI, ACIPHEX® (rabeprazole sodium), to include the treatment of daytime and nighttime heartburn and other symptoms associated with gastroesophageal reflux disease (GERD). ACIPHEX® was discovered and developed by Eisai Co., Ltd., and is co-marketed in the United States by Eisai Inc. and Janssen Pharmaceutica Inc.
Symptomatic GERD is characterized by the presence of symptoms such as heartburn, regurgitation, belching and early satiety (feeling of being full sooner than normal or after eating less than usual) without endoscopic evidence of erosion to the esophagus.
More than 60 million Americans experience heartburn, the most common manifestation of symptomatic GERD, on a monthly basis. In these patients, heartburn may also be accompanied by regurgitation, which occurs when digestive acids travel back up the esophagus into the mouth. “This approval offers proof for patients and physicians that ACIPHEX® is an effective treatment for the nagging symptoms of GERD,” said Susannah Spiess, M.D., F.A.C.P., attending gastroenterologist at Evanston Northwestern Healthcare and assistant professor at Northwestern University Medical School, Chicago, IL. “ACIPHEX® provides 24-hour acid control with the first dose and relieves the discomfort of GERD.” In two pivotal clinical trials, the percentage of heartburn-free daytime and/or nighttime periods was significantly greater with ACIPHEX® (rabeprazole sodium) 20mg compared to placebo. In addition, ACIPHEX® was shown to significantly reduce daily antacid consumption versus placebo over four weeks of therapy. In the study involving approximately 200 patients, ACIPHEX® provided significant reduction in daytime and nighttime heartburn symptom severity associated with GERD on the first day of treatment, and was also superior to placebo in reducing belching, early satiety and regurgitation in weeks two and four of treatment.
About the Trials Two U.S., multicenter, double-blind, placebo controlled studies were conducted in 316 patients with daytime and nighttime heartburn. Patients reported five or more periods of moderate to very severe heartburn during the placebo treatment phase the week prior to randomization. Patients were confirmed by endoscopy to have no esophageal erosions. Eligible subjects were given either ACIPHEX® 10mg, 20mg or placebo, and a diary to record severity of GERD symptoms; subjects returned at week two and four for efficacy assessments. In these studies, the most common adverse events assessed as possibly related to rabeprazole 20mg and occurring at a frequency of greater than two percent were abdominal pain, diarrhea and headache.
About ACIPHEX® Nearly 14,000 patients have participated in ACIPHEX® clinical trials worldwide. The U.S. Food and Drug Administration approved ACIPHEX® 20mg tablets for marketing in August 1999. Prior to its U.S. approval, rabeprazole sodium was first approved in Japan in 1997, in the United Kingdom in 1998 and subsequently in all 14 other European Union countries. The drug, known as PARIET® outside of the United States, has been launched in 59 countries.
In addition to its new indication for the treatment of symptomatic GERD, ACIPHEX® is indicated for healing of erosive GERD (caused when the lining of the esophagus is damaged by long-term acid exposure), maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of related symptoms of these conditions. ACIPHEX® also is approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ACIPHEX® product labeling recommends once-daily dosing for most indications.
In clinical trials for erosive GERD, ACIPHEX® (rabeprazole sodium) demonstrated a favorable side-effect profile. Headache was the most common side effect assessed as possibly related to ACIPHEX® (2.4 percent versus 1.6 percent for placebo). ACIPHEX® is contraindicated in patients with known sensitivity to rabeprazole, substituted benzimidazoles or any component of the formulation. As is the case for other proton pump inhibitors, symptomatic response to therapy with ACIPHEX® does not preclude the presence of gastric malignancy. Patients treated with proton pump inhibitors, including rabeprazole sodium, and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Proton pump inhibitors constitute an established class of drugs that has been shown to be effective and well tolerated.
ACIPHEX® is a registered trademark of Eisai Co., Ltd., Tokyo, Japan, and is co-promoted by Eisai Inc. and Janssen Pharmaceutica Inc. in the United States.
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