Knoll Meridia

Executive Summary

Two-year safety data added to labeling from the company's STORM study. While Knoll reports that 70% of patients in the study maintained a 5% weight loss for the duration of the study compared to 44% of placebo patients, only safety data from the study was added to labeling. Meridia revised labeling states that the "safety and effectiveness...have not been determined beyond two years at this time." Previously, labeling limited the experience to one year from trials conducted for approval of the drug. Labeling also adds blood pressure data from a 26-patient study showing increases in systolic and diastolic blood pressure for the drug compared to placebo. Meridia labeling contains a warning about substantial increases in blood pressure. Meridia had sales of $94.5 mil. in 2000 compared to $201 mil. for Roche's Xenical, according to IMS Health data