Ketotransdel: Final Phase III data

Final data from the intent-to-treat (ITT) population (n=361) of a double-blind, U.S. Phase III trial showed that 1g thrice-daily topical Ketotransdel for 7 days missed the primary endpoint of significantly reducing pain intensity as measured by VAS scores from baseline to day 3 vs. placebo (p=0.087). In the modified ITT (mITT) population (n=326), which excluded 35 patients who did not meet study entry criteria at the time of enrollment, Ketotransdel did significantly reduce pain intensity from baseline to day 3 vs. placebo (p=0.038).

Additionally, a significantly greater proportion of patients in the mITT population treated with Ketotransdel were satisfied with their treatment and achieved moderate or high pain relief as measured by a 7-point Likert scale on day 3 vs. placebo (p=0.023). Transdel said the 35 patients - 30 who tested positive for recreational drug use, 4 with exclusionary laboratory assessments and 1 with an incorrect diagnosis - should not have been enrolled in the trial based on information that was not known at the time of enrollment. Data were presented at the International Association for the Study of Pain meeting in Montreal. ...