We would like to thank Dr. Wartell for his interest in parecoxib sodium. In planning this and other studies of the analgesic effects of parecoxib sodium, we followed a process of orderly, sequential drug development. Clearly, it is not feasible to conduct all potential studies of interest at the initiation of a program or simultaneously; therefore, we elected to begin our study of parecoxib sodium with a comparison study against another injectable analgesic that worked through inhibition of cyclo-oxygenase. We considered that this would provide a reasonable benchmark from which to progress to further trials.
We considered a study versus ibuprofen, but recognized that comparison of a parenteral analgesic with an oral medication may be subject to criticism, on the basis of pharmacokinetic differences that result from different routes of administration. Furthermore, it should be noted that parecoxib sodium is actually a prodrug of valdecoxib; valdecoxib is suitable for oral administration and is being evaluated in a related program. We felt that comparison of valdecoxib with ibuprofen represents a more suitable comparison than parecoxib sodium versus valdecoxib; results of those studies will be published separately.
Additionally, studies evaluating preoperative dosing of both parecoxib sodium and valdecoxib are in progress.
