The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application, and provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to support regulatory approval.
Simon Pedder, Chelsea’s president and CEO, said: “We believe this agreement further reduces our development risks by specifically defining the path to marketing approval for Droxidopa. With our first pivotal efficacy and safety trial (study 302) actively underway, this agreement clears the way to aggressively move forward with the second of the two required studies.”