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| |  FDA Clears TAP’s Prevacid For GERD DEERFIELD, IL -- April 13, 1998 -- TAP Holdings Inc. announced today that it received approval from the U.S. Food and Drug Administration (FDA) for Prevacid® (lansoprazole) Delayed-Release Capsules in the short-term treatment of Symptomatic GERD. The most common symptom of GERD is heartburn caused by the reflux of gastric juices from the stomach into the esophagus. A study showed that patients taking 15 mg Prevacid had statistically superior relief from heartburn associated with GERD when compared with patients taking placebo. "The study showed that Prevacid is very effective at reducing the incidence and severity of day and nighttime heartburn associated with GERD," said James Freston, M.D., Ph.D., gastroenterologist and director of clinical research at the University of Connecticut Health Center. "Based on these findings and an earlier clearance for the treatment of erosive esophagitis, we believe that Prevacid is an ideal choice as first-line therapy for all stages of gastroesophageal reflux disease." GERD is an all-inclusive term for a range of symptoms that result from the exposure of the esophagus to gastric acid. Heartburn and regurgitation are the most common symptoms, appearing as abdominal pain and burning sensations in the chest. Approximately 10 percent of Americans experience heartburn each day. Although GERD is a manageable disease, mild forms can evolve into erosive esophagitis, a more serious condition in which the gastric contents of the stomach pass upward and cause inflammation and tissue damage to the esophagus. If left untreated, complications may occur, including hemorrhage, stricture, and Barrett’s esophagus, a condition associated with an increased risk of esophageal cancer. "The goals of therapy for GERD are to relieve symptoms, to heal esophageal injury if present, and to prevent complications and recurrence," said Dr. Freston. "In this regard, proton pump inhibitors such as Prevacid are effective because of their ability to stop the secretion of stomach acids." Clinical Study Support for the short-term indication is based on efficacy results from a study of 214 GERD patients with heartburn participating in a double-blind, placebo-controlled clinical trial conducted in the United States. This study compared eight weeks of treatment of Prevacid 15 mg given once daily versus placebo. For patients taking Prevacid 15 mg, 84 percent of patient-days were free from heartburn at Week 8 compared to 13 percent of days for patients receiving placebo. Likewise, for patients taking Prevacid 15 mg, 92 percent of patient-nights were free from heartburn at Week 8 compared to 36 percent of nights for patients receiving placebo. The most frequently reported adverse events included headache, abdominal pain and diarrhea. No clinically or statistically significant differences were noted in the incidence of adverse events between Prevacid and placebo. Prevacid is a proton pump inhibitor (PPI), which blocks the production of stomach acid by inhibiting the enzyme system responsible for acid secretion. In addition, the product is indicated for the short-term treatment of erosive esophagitis, maintenance of healed erosive esophagitis, in combination with Biaxin® (clarithromycin tablets, Abbott Laboratories) and amoxicillin for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, active benign gastric ulcers, and hypersecretory conditions including Zollinger-Ellison syndrome.
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