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BLOCK DRUG SEEKING ORAL SURGERY PAIN INDICATION FOR BC POWDER

Executive Summary

BLOCK DRUG SEEKING ORAL SURGERY PAIN INDICATION FOR BC POWDER, an OTC anti-inflammatory analgesic containing aspirin, salicylamide and caffeine. Block currently markets the product for treatment of minor aches and pains. The company says it is about five weeks into Phase II clinicals for the new indication. Block submitted a copy of the protocol to FDA on Jan. 14 and was subsequently notified by FDA that "no substantive changes" were necessary. The blinded, randomized trial is intended to "establish the pharmacological parameters of BC Powder in terms of onset of effect, peak effect, duration of effect and profile of side effects when compared to aspirin and placebo," Block says in its protocol. The powder's efficacy in alleviating pain in patients who have undergone oral surgery will be compared to placebo, 650 mg aspirin and 1300 mg aspirin. The test results will be used to evaluate the analgesic profile, the side effect profile and the bioavailability of BC Powder compared to aspirin and placebo. The study will also measure the correlation of blood levels of drug with analgesic efficacy. Under the protocol, 15 patients will receive BC Powder, 15 will receive 650 mg aspirin, 15 will receive placebo and five will receive 1300 mg aspirin. Patients will be healthy individuals (16- 65) who are "scheduled to undergo an oral surgical procedure involving limited bone removal that should result in moderate to moderately severe intensity postsurgical pain." Analgesic effects will be recorded by the patients in "self- rating diaries" at regular intervals following surgery and medication as follows: "Pain Intensity -- none, slight to moderate, severe; Pain Relief -- none, a little, some, a lot, complete; Pain At Least Half Relieved -- yes or no; Overall Evaluation -- poor, fair, good, very good, excellent." Patients who do not find the pain relief adequate will receive an appropriate "rescue medication," although the sponsor will encourage patients to wait two hours before considering a rescue analgesic. Adverse effects also will be recorded. In addition, blood samples taken at surgery and at regular intervals following drug administration will be "assayed for the presence of aspirin, salicyclic acid and salicylamide."
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