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Executive Summary

J&J TRAMADOL U.S. CHRONIC PAIN DATABASE OF 1,000 PATIENTS in three large Phase III trials of up to 24 months treatment will be submitted to FDA as part of the firm's NDA for both chronic and acute pain. Johnson & Johnson's R. W. Johnson Pharmaceutical Research Institute is currently "in the throes" of preparing the NDA, the firm said. U.S. clinical trials for acute pain comprising single and multiple dose trials include about 4,500 patients. U.S. trials were completed about a year ago. A name J&J trademarked for tramadol is Ultram. The oral analgesic, licensed to J&J in the U.S. from the German firm Gruenenthal in 1986, was launched in Germany in 1977 for acute and chronic pain and is currently marketed in 40 countries. Over 11.7 mil. patients have been treated with the drug, an exposure of over approximately 400 mil. doses, J&J estimated. The efficacy of tramadol is "really not at the morphine level," but J&J believes it is similar to that of weak opioid/NSAID combinations such as propoxyphene and acetaminophen (Darvocet and generics), R. W. Johnson principal scientist Robert Raffa, PhD, told a May 6 meeting in Philadelphia entitled "Advances in the Treatment of Chronic Pain." In "most of these clinical trials, tramadol in a dose-related fashion seems to be at about that level," Raffa explained. J&J is hoping to claim that tramadol has fewer side effects than other opioid analgesics, based in part on a preclinical study by R. W. Johnson and Gruenenthal suggesting that the drug, a racemic mixture, has an opioid and a non-opioid component to its analgesic action. Raffa's abstract asserts that unlike "typical opioid analgesics," tramadol use "is not associated with significant respiratory depression, sedation or other common side effects, nor are there signs of tolerance, dependence or euphoric effects." Gruenenthal originally launched and marketed the drug as an opiate. J&J's "working hypothesis," Raffa told the Cambridge Healthtech Institute-sponsored meeting, is that "the opioid component is predominantly [the] mu [receptor]...while the nonopioid component probably involves norepinephrine and serotonin uptake inhibition or release." Addressing the issue of dependence, Raffa noted that Gruenenthal has received about 17 to 20 reports a year of abuse problems with tramadol, a level that has remained steady while sales of tramadol have increased. The drug is not regulated as a controlled substance in any country where it is marketed, J&J noted. To support the claims of lower rates of respiratory depression and constipation for tramadol as compared to typical opioids, Raffa said preclinical data "do support the lack of side effects." The major side effects of tramadol are nausea and vomiting, other events associated with opioid analgesics. National Institute of Dental Research Neurobiology and Anesthesiology Branch Clinical Trials Unit Chief Mitchell Max, MD, challenged Raffa's statements about adverse events, saying that he had not seen enough clinical data to support it. "I hope that you did do the show [the favorable side-effect profile]...because I think there are going to be a lot of rooters for tramadol" if the drug does have the favorable side- effect profile.

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