REQUA CHARCO-CAPS 51-PATIENT DIARRHEA STUDY FOR CATEGORY I

Executive Summary

REQUA CHARCO-CAPS 51-PATIENT DIARRHEA STUDY FOR CATEGORY I submission produced "excellent" or "very good" relief of symptoms in 58% of patients receiving the activated charcoal product compared to 38% of placebo patients, the company reported in a recent study submission. The single-center, double-blind, placebo-controlled study of 51 patients with diarrhea associated with nonspecific gastroenteritis found that "58% of those receiving active therapy [reported] that they had an excellent or very good result of therapy compared to only 32% receiving placebo; only 15% of those receiving active therapy rated their responses fair or poor, whereas 44% of those receiving placebo recorded this rating," Requa said. In addition to patient assessment of improvement, the study evaluated efficacy of the ingredient by "determining the effect of Charco-caps on the consistency and frequency of bowel movements and the time to the appearance of the first formed stool" and "determining the effect of Charco-caps on the cramps associated with diarrhea, including the severity, frequency and duration of cramps," the firm said. Study data was gathered through patient diaries of bowel movements and abdominal cramps for the 48 hours following initial therapy. Subjects received either a bottle of 64 260 mg Charco-caps or a bottle of 64 placebo capsules for the two-day treatment period. "An examination of the total time from the onset of therapy to the last unformed stool revealed that Charco-caps resulted in a significantly shorter interval (11.7) as compared to placebo therapy (16.5; p < 0.001)," Requa reported. The time from initial treatment to the last abdominal cramp experienced was 5.1 hours in the Charco-caps group compared to 9.3 hours in the placebo group. "On a cramp per patient basis those individuals receiving Charco-caps experienced fewer cramps (1.35 cramp/person) than those receiving placebo (2.32), supporting the efficacy of therapy (p < 0.001)," Requa said. The company is requesting FDA to reopen the administrative record for the Anti-diarrheal Tenative Final Monograph (TFM) to reclassify activated charcoal from Category III to Category I prior to publication of the final monograph. The TFM, published in April 1986, allowed submission of new data supporting changes in ingredient status until April 30, 1987.