Wyeth Duract launch ads claim superiority to Ultram, herald nonscheduled status.
Executive Summary
WYETH DURACT LAUNCH TOUTS SUPERIORITY TO J&J's ULTRAM in a six-page journal advertisement pre-cleared by FDA. The ad launching the non-steroidal anti-inflammatory drug appeared in the New England Journal of Medicine and the Journal of the American Medical Association. "More power than Ultram 100 mg...in a single-dose study of oral surgery," the ad states. The ad references an unpublished study comparing Duract (bromfenac), Ortho-McNeil's Ultram (tramadol) and placebo conducted by SciRex in Austin, Texas. The study was submitted with the NDA but was not included in Wyeth- Ayerst's Duract labeling. The ad footnotes that the data is on file at Wyeth.