THOMPSON MEDICAL ASPERCREME EFFICACY INFORMATION IN UNPUBLISHED ARTICLE

THOMPSON MEDICAL ASPERCREME EFFICACY INFORMATION IN UNPUBLISHED ARTICLE reviewing two recent studies was submitted to FDA by the firm in Feb. 7 comments. The company said two double-blind controlled studies comparing Aspercreme's active ingredient (trolamine salicylate) with aspirin "demonstrate that in terms of a risk/benefit ratio, treatment of minor pain with TEAS [trolamine salicylate] is superior to treatment with aspirin." The draft article reviewing the studies was by Iber, Shamszad and Golden. The article reviewed two studies comparing the pain relief obtained by patients given Aspercreme and two placebo tablets v. those who received a placebo ointment and two aspirin tablets. Aspercreme "produced a faster onset of action than aspirin and . . . was superior to aspirin in terms of the number of adverse reactions," Thompson said. The company also contended that "both studies confirmed the reports from clinicians and other clinical trials that topically applied TEAS is as effective as orally ingested aspirin in relieving minor pain associated with arthritis and rheumatism." The company also submitted summaries of other efficacy studies, including bioavailability testing. One such 1982 study "concluded that topical dosage of salicylate can produce high local subcutaneous concentration of the drug and pain relief in humans," Thompson said. An enclosed reprint of a paper published in the Dec. issue of the Journal of Pharmaceutical Sciences reviewed the 1982 study "and other bioavailability studies, all of which uniformly show high levels of TEAS at the sites of pain and low levels in the blood, as compared with salicylate orally administered," the firm said. Thompson further maintained that review panels granted Category I status to other drugs that lack double-blind studies demonstrating efficacy. The Panel on External Analgesics "placed many ingredients in Category I based on wide use of the ingredient, its clinical acceptance, and published reports in the literature," it said. "Stronger ammonia water, juniper tar and turpentine oil were recommended for Category I status by the panel without controlled or uncontrolled studies, and the FDA Tentative Final Monograph followed these recommendations." "There is no reason that different standards should be applied to the determination of the status of trolamine salicylate for minor pain relief" than other drugs, Thompson declared. Citing the panel's recommendation for Category I status for methylsalicylate "without well-controlled clinical studies," the company said the recommendation was based on four studies, none of which meet the requirements that are now sought to be imposed on the TEAS studies." Thompson maintained there were no studies on the ingredient by itself nor any blood level determinations of methylsalicylate, which is used in combination with menthol in OTC topical analgesics such as Ben-Gay and Mentholatum Deep Heating Rub.