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Bristol-Myers Squibb's Stadol

Executive Summary

"NDA Day" set for June 24 with FDA's Pilot Drug Evaluation Staff to discuss nasal formulation of butorphanol. BMS is seeking an indication for the treatment of moderate to severe pain -- the same as that of the already-marketed oral formulation of the drug. The company has looked at nasal formulation for migraine, post- operative pain and pain associated with dental surgery. FDA's Drug Abuse Advisory Committee recommended in February that BMS use post-marketing surveillance to study the abuse potential of nasal delivery Stadol. FDA advisory committees have looked at oral butorphanol's abuse potential seven times previously; the drug has not been scheduled for DEA control.
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PS019341

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