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Executive Summary

ASTRA ESTIMATES THAT .2% OF DALGAN SHIPMENTS ARE MISSING after two years on the market, the company told FDA's Drug Abuse Advisory Committee at a Feb. 27 meeting. Updating the panel on Astra's efforts to determine whether doctors are abusing the opioid mixed agonist/antagonist anesthetic Dalgan (dezocine), Astra VP-Medical Affairs Nigel Rulewski said that about 1,000 units of "over half a million" total units shipped are unaccounted for, or about .2%. Some of the missing units are "probably" due to abuse, Rulewski added, but noted that to date the only abuse the company has confirmed are two doctors who repeatedly reordered Dalgan claiming that shipments were missing or incomplete. Rulewski proposed "that the next step we should take is to survey treatment centers for physicians" to determine if doctors are abusing Dalgan. Because Dalgan is an injectable, initial signs of abuse are more likely to appear among physicians than other segments of the population. "We have obtained a list of [National Institute of Drug Abuse] certified centers for physicians.... We would propose within a year or so's time to do a survey of these addiction centers," Rulewski said. Both the committee and FDA expressed enthusiasm for the physician treatment center survey. "I think you're doing the kind of thing that we had in mind," Pilot Drug Evaluation Staff Director John Harter, MD, said. He agreed that Astra should pursue the physician abuse survey "this year and then when you come back to report we can decide what to do next year." Dezocine is manufactured in bulk in France by Roussell-UCLAF, packaged in the U.S. by Wyeth-Ayerst, and marketed by Astra. It had been discussed at three previous meetings of the Drug Abuse Advisory Committee. In August 1989, prior to approval, the committee voted that the drug should be a Schedule V controlled substance, although some members felt it need not be scheduled at all. It was approved in December 1989 as an unscheduled drug. NDA- holder Wyeth-Ayerst, who subsequently licensed Dalgan to Astra, committed to Phase IV studies of the drug's abuse potential prior to approval. Astra discussed the postmarketing surveillance plans before the committee in June 1990 ("The Pink Sheet" June 11, 1990, T&G-5) and February 1991 ("The Pink Sheet" Feb. 11, 1991, p. 10). Sales of the drug have been relatively limited. Rulewski began his presentation by noting that "Dalgan cannot be described as a blockbuster drug." Sales for 1991 totaled about $2 mil., with volume totaling about 500,000 units, he said. While sales increased throughout the year, "it is still a very small drug for us," Rulewski said. In June 1991, Astra conducted a survey of 198 hospitals that buy Dalgan direct from the company, Rulewski said. A total of 721 physicians responded, of which 82% considered Dalgan a "prescription" rather than a "controlled" drug in their hospital. None said they were aware of any diversion, theft, or abuse of Dalgan. Astra told the committee that it has developed assays to detect dezocine levels in urine and saliva which it intends to provide to addiction centers. However, Rulewski said that providing assay kits will be expensive, and he asked whether NIDA would share the cost. NIDA representative James Cooper, MD, told Rulewski that the answer to his question is a "probable yes" but added that "this is the first I've heard of it." The committee recommended that FDA and NIDA discuss the matter and provide a firm answer for Astra. "I think it unreasonable that you bear the sole cost of putting out these kits," Committee Chairman Theodore Cicero, PhD, Washington University School of Medicine, told Astra, "especially since your profit margin at this point doesn't seem like it is especially large with this compound. I'd hate to discourage you from keeping it on the market." Cicero also proposed that FDA and NIDA discuss whether other manufacturers of agonist/antagonist anesthetics can share the financial burden, an idea first discussed at the June 1990 meeting. Rulewski estimated that the hospital survey cost Astra about $150,000, and he estimated that the proposed physician treatment center survey would cost about the same. Later in the meeting, Harter told the committee that "we've been lucky with dezocine. I think [Astra has] done a better job than many of the people we get commitments for Phase IV studies from. Lots of times...people don't go out and do things that look like what we had in mind."

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