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Executive Summary

STERLING's PENTAZOCINE IS SHOWING 70% REDUCTION IN ABUSE IN DAWN (Drug Abuse Warning Network) data for the nine-month period April-December, 1983, the company told House Crime Subcmte. Chairman Hughes (D-NJ) in an April 12 letter. Reporting the effect of the new naloxone/pentazocine combo, Talwin-NX, on street abuse patterns, Sterling told the House subcmte. that DAWN reports continue to show a decline in pentazocine mentions. At an FDA meeting last fall, DAWN data for the first six months of Talwin-NX marketing showed an almost 75% reduction in abuse mentions for pentazocine. The updated figures through the end of the year indicate that the reduction in abuse of the chemical is continuing. The Sterling letter to Hughes follows a Feb. 22 Crime subcmte. hearing on drug diversion at which a witness (Robert Weiss, prosecuting attorney for Michigan's Genesee County) testified that addicts were "burning off" the layer of naloxone contained in the reformulated Talwin-Nx in order to eliminate its intended narcotic antagonist effect upon injection ("The Pink Sheet" Feb. 27, p. 3). In the letter to the Hill, Sterling asserts that it "has actively sought, but found no evidence in support of those claims." Sterling further asserted that tests to determine whether abusers can successfully remove naloxone from Talwin-Nx demonstrate that the reformulation is effective. In one study, the firm duplicated the method of "burning off" the naloxone as demonstrated by an abuser, and found that naloxone was present "in the same ratio of 1:100 (naloxone to pentazocine) as exists in the newly formulated tablet." In another study, Sterling found "allegations by addicts that naloxone could be removed by boiling the tablets in water proved to be inaccurate." The company conducted several studies in which they boiled the tablets for 5, 10, 15 and 30 minutes without finding an altered ratio of the two drugs. Sterling further maintains that the tests "confirmed our contention that the reformulated combination of pentazocine and naloxone can not be easily altered for misuse as alleged." The company contends: "Information obtained by various routes, including on-the-spot investigation and discussion with various local enforcement and medical officials from coast to coast, supports our belief that the reformulation is proving effective in curbing the misuse of pentazocine."

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