PREVACID® (LANSOPRAZOLE) IS FIRST PROTON PUMP INHIBITOR APPROVED FOR HEALING AND RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS LAKE FOREST, IL, December 5, 2000 - TAP Pharmaceutical Products Inc. announced today that the U.S. Food and Drug Administration has approved TAP's proton pump inhibitor (PPI), PREVACID® (lansoprazole), for healing and risk reduction of NSAID-associated gastric ulcers. These new indications build on PREVACID's established foundation as the PPI with the most indications and administration options. NSAIDs (non-steroidal anti-inflammatory drugs), such as aspirin, are used for conditions such as headache, arthritis and musculoskeletal pain. NSAIDs are one of the most widely used classes of drugs, with millions of prescriptions and billions of over-the-counter tablets sold every year in the U.S. Continuous use of NSAIDs can irritate the stomach and may cause ulcers. "With these new indications, PREVACID will help patients who regularly use NSAIDs and suffer from related gastric ulcers," said Art Rice, vice president, marketing, TAP. "PREVACID represents an important therapy that will allow patients to continue their NSAID treatment while healing NSAID-associated gastric ulcers or reducing the risk of their recurrence." Clinical Studies The FDA approval was based on three large, multicenter, double-blind clinical trials. Two studies evaluated the healing of NSAID-associated gastric ulcers and another study evaluated the risk reduction of NSAID-associated gastric ulcers as determined by the absence of their recurrence during the study period. Healing The two studies supporting the healing indication compared PREVACID once-daily with an active control in patients with an endoscopically confirmed NSAID-associated gastric ulcer who continued their NSAID use. The percentage of patients healed after eight weeks was statistically significantly higher with PREVACID 30 mg than with the active control. In the first study, gastric ulcers healed in 79 percent of those treated with PREVACID 30 mg (n=79), compared with 55 percent of those treated with the active control (n=74), after eight weeks. In the second study, gastric ulcers healed in 77 percent treated with PREVACID 30 mg (n=61), compared with 50 percent treated with the active control (n=66), after eight weeks. Controlled studies did not extend beyond eight weeks. Risk Reduction The study supporting the risk reduction indication compared PREVACID 15 mg and PREVACID 30 mg once-daily with misoprostol 200 mcg four times daily and with placebo in patients who required chronic use of NSAIDs and who had a history of an endoscopically documented gastric ulcer. The percentage of patients remaining free from a gastric ulcer after four, eight and 12 weeks was significantly higher with PREVACID 15 mg, PREVACID 30 mg, and misoprostol 200 mcg than placebo. By week 12, 80 percent of those treated with PREVACID 15 mg (n=121), 82 percent of those treated with PREVACID 30 mg (n=116), and 93 percent of those treated with misoprostol (n=106) remained gastric ulcer free, compared with 51 percent given placebo (n=112). Treatment-related diarrhea occurred in 22 percent of patients given misoprostol, 5 percent with PREVACID and 3 percent with placebo. Controlled studies did not extend beyond 12 weeks. PREVACID 15 mg is the approved dosage for this indication. "Although NSAIDs have a clear benefit for many patients, these drugs can cause gastric ulcers. This is a serious concern for patients as well as physicians," said John Seely, vice president, research and development, TAP. "These findings clearly show PREVACID safely and effectively heals NSAID-associated gastric ulcers and can significantly reduce the risk of their recurrence." About PREVACID® (lansoprazole) PREVACID is a PPI which decreases the production of stomach acid by blocking the tiny pumps responsible for acid secretion. PREVACID is indicated for the treatment of symptomatic gastroesophageal reflux disease (GERD); treatment of active benign gastric ulcers; treatment and maintenance of duodenal ulcers; treatment and maintenance of erosive esophagitis, a condition in which the lining of the esophagus becomes inflamed and damaged; and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, which involves the overproduction of stomach acid. Symptomatic response to therapy does not preclude the presence of gastric malignancy. PREVACID is contraindicated in patients with known hypersensitivity to any component of the formulation. The most frequently reported adverse events include diarrhea, abdominal pain, and nausea. For further information on PREVACID, please see the complete prescribing information and visit www.prevacid.com. About TAP Pharmaceutical Products Inc. TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd., of Osaka, Japan. TAP also markets Lupron Depot® (leuprolide acetate for depot suspension). TAP has also filed a New Drug Application with the U.S. Food and Drug Administration for the cephalosporin antibiotic SPECTRACEF™ (cefditoren pivoxil). |
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