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Executive Summary

RESEARCH INDUSTRIES' DMSO NDA FOR SCLERODERMA WILL BE RESUBMITTED with a relief of pain claim instead of a hand ulcer healing claim, the firm said. The decision to seek a scleroderma pain relief claim followed FDA's Arthritis Advisory Cmte.'s conclusion at its May 20 meeting that a new study submitted by the firm did not establish safety and efficacy of the agent's use in scleroderma patients. At the meeting, FDA Anti-inflammatory Drugs Group Leader John Harter, MD, commented that the date were more suggestive of efficacy in pain relief than in healing of hand ulcers. Harter said that because many patients were using NSAIDs during the course of the study, ulcer healing should be the only efficicacy endpoint evaluated. Research Industries told "The Pink Sheet" that it met with FDA officials following the meeting to plan submission of a new application based on the relief of pain associated with scleroderma. The firm has been marketing DMSO for interstitial cystitis since 1978. Research Industries presented the results of a six month study conducted by the Cooperative Systemic Studies for Rheumatic Diseases Group (CSSRDG). The CSSRDG study evaluated the safety and efficacy of topical DMSO in reducing hand ulcers, pain, and in softening skin, in 55 patients randomized to receive DMSO 70% solution, or placebo (either DMSO 2% solution or saline). The double-blind study was conducted at FDA's request following the agency's denial of Research Industries' supplemental NDA for the scleroderma indication in 1981. Prior to cmte. consideration of the CSSRDG data, FDA Office of Drug Research and Review Director Robert Temple, MD, reminded the cmte. that the only other study contained in the supplemental NDA was an uncontrolled Cleveland Clinic study and that FDA typically approves drugs on the basis of two controlled trials. However, he said that because scleroderma is rare and it is difficult to collect patients, FDA "was certainly prepared to rely on a single persuassive study . . . as support for approval." Temple emphasized that FDA "would expect the data in such a case to be quite persuasive, not marginal." Summarizing the cmte. consensus on the CSSRDG data, Cmte. Chairman Michael Weisman, MD, University of California Medical Center, San Diego, said: "The cmte. has voted that there is no clear and convincing persuasive evidence of safety and effectiveness under the circumstances for DMSO presented today." Several cmte. members, however, commented that the data were suggestive of an effect. Cmte. member Robert Pinals, MD, Rutgers School of Medicine, for example, commented that "the evidence again is somewhat suggestive that there is an effect, but . . . I'm not convinced."

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