Salix Pharmaceuticals Ltd.’s use of an adaptive clinical trial design to support its Fulyzaq (crofelemer) application allowed the company to consolidate dose-finding and the pivotal efficacy assessment in a single trial, and by enrolling the two stages of that trial independently Salix gave FDA confidence that the effect was seen in two trial populations.
The Fulyzaq program is part of an emerging trend in clinical trials: the treatment for diarrhea associated with anti-HIV therapy...