BMS caffeine study

Executive Summary

Bristol Myers-Squibb requests teleconference with FDA in "near future" to discuss several questions generated by agency comments on firm's clinical study proposal for trial comparing effects of aspirin/acetaminophen/ caffeine in varying doses with acetaminophen 1,000 mg alone. Excedrin marketer submitted study protocol in July 2001; FDA responded in February that acetaminophen-only arm is unnecessary, trial should include second pain model other than headache (1"The Tan Sheet" Feb. 25, 2002, p. 9). In May 31 submission, BMS maintains "we believe that many of the issues raised [by FDA] will be answered by providing the agency with a full protocol, rather than the protocol outline we submitted" in July. Complete protocol will be submitted after the teleconference, firm says...