HOECHST-ROUSSEL's OTC DANTHRON LAXATIVE STUDY EFFICACY RESULTS

Executive Summary

HOECHST-ROUSSEL's OTC DANTHRON LAXATIVE STUDY EFFICACY RESULTS show the compound is effective at a 50 mg once-daily dose, the firm said in a July 2 submission to FDA. The study "achieves statistically significant (p. <.01) efficacy for danthron 50 mg vs. placebo [for both] number of bowel movements per week [and] total grams excreted per week," the firm reported in a July 2 study submission to FDA in support of Category I status in the OTC Laxative Final Monograph. FDA's January OTC Tentative Final Monograph for Laxative Drug Products listed danthron as Category I for a single daily dosage of 75 to 150 mg. Hoechst is seeking a monograph listing for a single daily dose of 50 mg danthron. Hoechst's double-blind cross-over study compared the efficacy of 50 mg danthron to placebo in eight patients with chronic constipation. Patients were given either active drug or placebo for seven days following a seven-day no-treatment stabilization period. In addition to finding statistically superior efficacy of danthron for bowel movements per week and total grams excreted per week, the firm reported that "all eight patients had more bowel movements during the seven days of danthron administration than during both the placebo and screening control periods combined (14 days)." nistration than during both the placebo and screening control periods combined (14 days)."