PREVACID® (LANSOPRAZOLE) PACKET FOR ORAL SUSPENSION IS A SAFE AND EFFECTIVE ALTERNATIVE TO CAPSULES Lake Forest, Ill., May 20, 2001 - TAP Pharmaceutical Products Inc.'s newly-approved PREVACID® (lansoprazole) for Delayed-Release Oral Suspension is equivalent to the capsule formulation which is used in the treatment of acid-related disorders, such as gastroesophageal reflux disease (GERD), according to a study presented during Digestive Disease Week. This data supports the approval by the U.S. Food and Drug Administration of PREVACID Packet for Oral Suspension on May 3, making it the first proton pump inhibitor (PPI) available in this formulation. PREVACID Packet for Oral Suspension will be available later this year. Data from two randomized trials evaluating PREVACID 15 mg and 30 mg showed that PREVACID is absorbed into the bloodstream equally when administered as a capsule or as an oral suspension. "This new packet for oral suspension meets an important need for patients with certain acid-related disorders, especially those who have difficulty swallowing capsules," said Mitchell Rosenberg, MD, Clinical Director of Parkway Research Center in Miami, Fla. "Patients suffering from GERD now have another convenient administration alternative to PREVACID capsules." PREVACID Packet for Oral Suspension expands administration options The new PREVACID formulation, which will be available in packets with strengths of 15 mg and 30 mg, eliminates the need to swallow or open a capsule for alternative administration options. Patients can simply empty the strawberry flavored contents into a container with two tablespoons of water, stir well, and drink immediately. If any of the contents remains after drinking, patients should add more water, stir, and drink immediately. Patients may not mix the oral suspension with other liquids or foods, and should not crush or chew the granules. In addition to the packet for oral suspension, PREVACID is available in 15 mg and 30 mg capsules, which can be taken orally or opened to allow patients to sprinkle the intact granules onto select soft foods and juices. "PREVACID's broad array of administration options underscores our commitment to the various needs of the patients we serve," said Art Rice, vice president of marketing at TAP. "TAP is dedicated to the treatment of GERD, an often painful condition." This new administration option further builds on PREVACID's established foundation as the PPI with the most indications and administration options. About PREVACID® (lansoprazole) PREVACID is a PPI that decreases the production of stomach acid by blocking the tiny pumps responsible for acid secretion. The new PREVACID Packet for Oral Suspension can be used for all of the same indications as the capsule formulation, including 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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