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BRISTOL-MYERS EXCEDRIN DATA WILL GO BEFORE ADVISORY COMMITTEE

Executive Summary

BRISTOL-MYERS EXCEDRIN DATA WILL GO BEFORE ADVISORY COMMITTEE as part of a review of the safety and efficacy of caffeine as an analgesic adjuvant, FDA Office of Drug Evaluation I Director Robert Temple, MD, told the firm at a Feb. 15 OTC "feedback meeting." FDA's Arthritis Drugs Advisory Committee will probably meet sometime in the summer, after Bristol-Myers submits the results of three recently completed studies on Excedrin (500 mg aspirin, 500 mg acetaminophen and 130 mg caffeine). FDA had been planning to have the advisory committee review the data on caffeine at an April meeting, but the agency decided at the feedback meeting to delay the review until Bristol-Myers can finish compiling data from three recent studies. Bristol-Myers also recently submitted the results of six efficacy studies comparing Excedrin to J&J's Extra Strength Tylenol (acetaminophen 1000 mg) and placebo ("The Pink Sheet" Jan. 9, T&G-4). The firm has been conducting the studies to support reclassification of caffeine from a Category III to a Category I analgesic adjuvant. FDA Arthritis Group Leader John Harter, MD, noted at the meeting that the advisory committee will also review new safety data on caffeine as an analgesic adjuvant. Harter said that results of the safety studies are confidential and will have to be discussed in a closed session of the advisory committee. He noted that the party conducting the studies also cannot be disclosed. In addition to the new safety information, the agency is apparently asking the advisory committee to help in the review because of a number of complicating factors involved with assessing the efficacy of caffeine as an analgesic adjuvant. For example, the agency is concerned that the caffeine component of Excedrin may not cause the increased efficacy seen in some of Bristol-Myers' Excedrin v. Extra Strength Tylenol studies. Temple explained that if aspirin has a greater analgesic effect than acetaminophen, any increased effect seen with Excedrin could be due to the aspirin component of the product and not the caffeine component. To help resolve that issue, FDA plans to ask the advisory committee to review old data that the OTC analgesic panel relied on to form the conclusion that acetaminophen and aspirin have equal analgesic effects. FDA is also interested in studies that other firms may have conducted with caffeine and aspirin, acetaminophen or other NSAIDs. FDA OTC Division Director William Gilbertson, PharmD, suggested that the Proprietary Association could inform its members of the upcoming advisory committee and FDA's interest in gathering additional data for review.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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