P&G PEPTO BISMOL EFFICACY STUDY ON RELIEF OF DIARRHEA

P&G PEPTO BISMOL EFFICACY STUDY ON RELIEF OF DIARRHEA found that the average time to "total relief" for diarrhea patients using bismuth subsalicylate was 35.9 hours compared to 47 hours for the patients on placebo, Procter and Gamble told FDA officials at an Aug. 21 feedback meeting. Results of the study show that bismuth subsalicylate, the active ingredient in Pepto Bismol, "controls diarrhea by significantly reducing the duration of the disease state," P&G biostatistician Tim Balm asserted. Patients in the study received either placebo (50 subjects) or bismuth subsalicylate (49 subjects) in 525 mg doses every half hour for eight doses (4.2 mg/day) over a two day treatment period. Efficacy of bismuth subsalicylate was also statistically superior to placebo for a second efficacy parameter -- time from baseline to last unformed stool, Balm said. The time to last unformed stool for patients on the bismuth subsalicylate regimen was 24.7 hours compared to 33.7 for patients on placebo. All patients were adults. The study was one of five studies P&G presented to FDA in support of a Category I classification for bismuth subsalicylate. The ingredient was put in Category III in the Antidiarrheal Tentative Final Monograph, published in the April 30 Federal Register. P&G noted that it would formally submit the new studies to FDA in the near future. Under the antidiarrheal Tentative Final Monograph, efficacy of products must be established for any one of three possible claims for which a sponsor can label an OTC antidiarrheal product ("The Pink Sheet" May 5, p. 10). The three possible indications are: (1) "reduces the number of bowel movements in diarrhea"; (2) "improves consistency of loose, watery bowel movements in diarrhea"; and (3) "for the treatment of diarrhea," or "controls (or stops) diarrhea." In response to a question from OTC Drug Evaluation Division Director William Gilbertson, PharmD, P&G noted that it would be seeking a "controls diarrhea" indication as well as the other claims. A second study reviewed by the firm examined the efficacy of bismuth subsalicylate compared to placebo in the treatmen of 30 infants with chronic diarrhea. The infants received 2.5 ml Pepto Bismol every four hours (262.5 mg/day) if under two years old, and 10 ml every four hours (1,050 mg/day) if over two. Balm reported that the study found that infants receiving bismuth subsalicylate "gained significantly more weight, and had significantly fewer stools which had significantly improved consistency" whereas the "placebo-treated [group] did not improve."