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Executive Summary

Caffeine use as an OTC analgesic adjuvant will not be considered by FDA's Arthritis Drugs Advisory Committee until 1990, FDA Division of OTC Drug Evaluation Director William Gilbertson, PharmD, informed Bristol-Myers in a March 21 letter. "It appears at this time that the advisory committee meeting to evaluate caffeine will not be held until sometime next year," Gilbertson told Bristol-Myers. "Accordingly, there will be sufficient time to accumulate and prepare all of the necessary data and other information prior to the Committee's meeting." The letter from FDA responds to concerns raised by Bristol-Myers following an OTC feedback meeting on Feb. 16 ("The Pink Sheet" Feb. 20, T&G-6). Initially, FDA had planned to have the advisory committee review caffeine at an April meeting, but the agency decided at the feedback meeting to put off the review until Bristol-Myers can finish compiling its data from three studies. Bristol-Myers is currently compiling data from three recent studies on Excedrin (500 mg aspirin, 500 mg acetaminophen and 130 mg caffeine) for review by the advisory committee. Previously, the firm submitted results of six efficacy studies comparing Excedrin to J&J's Extra Strength Tylenol (1000 mg acetaminophen) and placebo to support reclassification of caffeine as an analgesic adjuvant from Category III to Category I. Bristol-Myers also expressed to FDA its concern about a statement made during the feedback meeting that the advisory committee, in a closed session, will also review new safety data on caffeine. Gibertson noted that Office of Drug Evaluation I Director Robert Temple, MD, and Arthritis Group Leader John Harter, MD, mentioned that a new animal study suggests potential nephrotoxicity problems when caffeine is added to an undisclosed nonsteroidal anti-inflammatory drug. The company asked FDA to make publicly available any data considered by the committee in order to provide an opportunity for review and comment. "At this time, these data are confidential as part of an investigational new drug application and are not in the public domain," Gilbertson said. "In addition, at this time they are not being considered as part of the rulemaking for OTC internal analgesic drug products." He said that if the data is utilized in the rulemaking, then it will be made public. Whitehall Labs submitted two studies to FDA on March 20 for review by the advisory committee. The studies compare the activity of aspirin 800 mg and caffeine 64 mg (two tablets of Anacin) with aspirin 800 mg and placebo in relief of sore throat pain and headache pain. In the double-blind, single-dose sore throat pain study, 207 patients with acute sore throats associated with tonsillopharyngitis were randomized evenly to receive one of the three study agents. According to the study, at 15, 30, 45, 60, 90 and 120 minutes after dosing, patients assessed pain intensity, change in pain, and pain relief. "The percent increment in overall analgesia contributed by caffeine was clearly detected on all rating scales," the study says. The double-blind, single-dose headache pain study evaluated 139 patients with recurrent headache, who were evenly randomized to receive one of the three study treatments. Pain intensity was evaluated at baseline and 0.5, 1, 1.5, 2, and 3 hours after treatment. "Pain intensity ratings had decreased by 46.7 to 53.3% from baseline at the 1.5, 2 and 3-hour evaluation points in the aspirin caffeine group, compared to 33.3 to 40% in the aspirin group, and 10 to 23.3% in the placebo patients over this same time span," the study said.

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