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Medicated Chewing Gum May Help Fight Against H. Pylori MINNEAPOLIS, May 6, 1997 -- A double-blind clinical study in 27 patients with gastroduodenal symptoms demonstrated efficacy of a medicated chewing gum containing colloidal bismuth subcitrate in eradication or substantial reduction of Helicobacter pylori (H. pylori). H. pylori is the bacterium that causes peptic ulcer disease. Eradication of H. pylori has been demonstrated to heal peptic ulcers and lead to long-term relief. Peptic ulcer disease affects approximately 4.5 million people in the United States. The study was conducted by Orphan Medical, Inc. Orphan licensed the product from Josman Laboratories, Inc. of California, who invented the technology and currently has 17 global patents pending. Current therapy focuses on eradication of H. pylori in the stomach using multiple drugs administered orally. The treatment fails when patients do not comply with the challenging treatment regimen, or when the organism causing the ulcer is resistant to the antibiotics used. In addition, the rate of recurrence of ulcers is fairly high. It is widely reported in the medical literature that H. pylori colonizes heavily in dental plaque on the surface of teeth and in the sulcus of gums in many patients with a history of duodenal or peptic ulcers. H. pylori in the mouth is outside of the systemic circulation and is therefore not affected by oral or intravenous drugs. Some physicians believe that the recurrence of ulcers is promoted by reinfection of the stomach by saliva, containing bacteria from the reservoir of H. pylori in the mouth. The Company believes that H. pylori in the mouth can be reached and treated with a chewing gum formulation. The data from the trial demonstrated reduction of H. pylori in the stomach. The clinical trial was conducted under a Food and Drug Administration (FDA) sanctioned investigational new drug application (IND), and all patients who received the medicated gum demonstrated either eradication or a marked reduction in H. pylori. None of the patients who received placebo gum had a reduction of H. pylori to the normal range, and most had no significant changes in H. pylori. The medicated gum tastes similar to commercially available chewing gums. "We are highly encouraged by the results of this investigation. The treatment of peptic ulcers remains a challenge for many physicians and patients," said Bertram Spilker, Ph.D., M.D., President of Orphan Medical. “A medicated chewing gum offers a product that is easy to use, would encourage a higher treatment compliance, and could reduce health care costs associated with recurrence of ulcers. It could be used as either a stand-alone treatment or as an adjunctive therapy for patients with H. pylori to prevent or reduce the rate of ulcer recurrences. Bismuth salts have been used in medicine for over 200 years, and tablet and liquid forms of colloidal bismuth subcitrate are currently used worldwide by millions of patients to treat ulcers. Orphan Medical is considering whether to seek a pharmaceutical partner to fully explore the future development, regulatory approval, and global marketing potential for this product. Orphan Medical, Inc. is dedicated to patients with inadequately treated or uncommon diseases. Orphan Medical acquires, develops, and markets products of high medical value to well-defined patient populations treated by health care specialists. E-mail this page to a friend or colleague! To print, use this version