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CPMP ASKING FOR SHORT-ACTING HYPNOTICS RISK/BENEFIT ANALYSIS

Executive Summary

CPMP ASKING FOR SHORT-ACTING HYPNOTICS RISK/BENEFIT ANALYSIS in a Dec. 11 opinion following second hearing on Upjohn's Halcion (triazolam). The European Community's Committee on Proprietary Medicinal Products heard presentations from Upjohn and "rapporteurs" from France, Germany, Greece and Italy charged with evaluating clinical data on Halcion. The CPMP concluded that "in order to complete the excellent work done by the rapporteurs, the committee has invited them to fully assess the relative risk/benefit ratio of all short acting hypnotics." In addition,"the safety in clinical use of all hypnotics will continue to be monitored by the committee." The CPMP determined that it need take no action regarding Halcion beyond its opinion of Oct. 16, which requested labeling changes, unit-of-use packaging and a postmarketing study. At its October meeting, the CPMP had deferred a final decision until December pending a full review of the data ("The Pink Sheet" Oct. 21, p. 9). "The committee confirms the safeguard measures as indicated in its position statement" of Oct. 16, the Dec. 11 opinion states,"particularly with regard to the maximum dosage of 0.25 mg, the narrow and very precise indications, as well as contraindications, for this product [and] the absolute importance of short-term usage (not more than 10 days), which has been reinforced by the introduction of small-pack sizes in all member states." The withdrawal of triazolam in the U.K. on Oct. 2 precipitated the CPMP meetings. The U.K. action followed a reanalysis of Halcion safety data that was prompted by Upjohn's disclosure of a "transcription" error in one of its clinical trials used to support the Halcion NDA. U.K. authorities observed the CPMP meeting but did not participate "in order not to prejudice the U.K. appellate procedure," the CPMP said. Upjohn's appeal of the U.K. action was heard Dec. 3, but a decision had not been issued as of Dec. 12. Upjohn said it is "pleased" with the CPMP action. The company noted that, while CPMP opinions are not binding on member states, individual countries "are required to decide on a course of action within 60 days" of notification of the CPMP opinion. Upjohn added that it is continuing to work with the CPMP on the issue. Upjohn appears successfully to have deflected a focus on Halcion's side effects that threatened worldwide withdrawals into regulatory initiatives on relabeling the whole class of drugs. FDA said Nov. 20 that, after agreeing to labeling changes and repackaging for Halcion, it would be seeking similar changes for all benzodiazepine insomnia products ("The Pink Sheet" Nov. 25, p. 11). Letters to benzodiazepine manufacturers were sent Dec. 3 (see following T&G).

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