Eisai Inc. and Janssen Pharmaceutica Inc. reported 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 4 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 2 and 4 of treatment.
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 2 and 4 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.