Pharma Blog Watch

A Look at Withdrawal Design (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses a recent announcement by Schwarz Pharma about its lacosamide Phase III study, which was a "withdrawal-design trial."

"The potential benefits of withdrawal designs are several-fold," he explains. "They allow all study subjects to receive a promising new treatment for at least part of the study period. They can be used to identify and enrich the re-treatment period with responders to reduce the likelihood of futile long-term treatment."

But, in this particular study, "subjects were all given lacosamide prior to withdrawal; there was no reported attempt to distinguish responders from non-responders prior to or during withdrawal," he writes. "Therefore, there was no enrichment in responders in the re-treatment phase, a lost opportunity to increase efficiency in that phase. Also, since withdrawal itself was not randomized (i.e. genuine vs. mock withdrawal), there was a missed opportunity to perform controlled tests of the withdrawal/re-introduction of lacosamide."