Glaxo Files For Ranitidine Bismuth Citrate Approval

Glaxo has filed an International Registration Dossier and New Drug Application for ranitidine bismuth citrate in the UK and USA. The applications are for RBC as a single agent for the management of duodenal ulcer and gastric ulcer, and in combination with an antibiotic (amoxicillin or clarithromycin) for the eradication of Helicobacter pylori and consequent prevention of relapse of peptic ulcer disease.

At a meeting in London to publicize the new product, Glaxo presented data from four studies evaluating the agent in comparison to Zantac (ranitidine) for the management of duodenal ulcer, which show that RBC is markedly superior to Zantac and can achieve four-week healing rates of up to 85%. A further study has also demonstrated superiority for RBC over Zantac in gastric ulcer patients, with healing rates at eight weeks of 86% and 75% respectively. However, a range of healing rates has been seen, with 80%-90% of patients healed at four weeks in Europe but just 50% of patients healed at four weeks in the USA. The company had no real explanation for this phenomenon.

Phase III Eradication Trials Results Preliminary results from eight new Phase III trials of RBC in combination with either amoxicillin or clarithromycin for the eradication of H pylori infection and treatment of duodenal ulcer disease were presented at the meeting by Jean-Pierre Isal, director of gastrointestinal medicine at Glaxo Research and Development.