Pozen plans to meet with the FDA to discuss its responses to the company’s proposed protocol for the Phase III pivotal studies, including the inclusion/exclusion criteria, the stratification plan, the primary endpoint, and the statistical methodology to be used in the study.
The company also plans to discuss an additional pharmacodynamic study requested by the FDA which would support the bioequivalence study previously conducted for PA32540.
The special protocol assessment (SPA) is a process by which the FDA and the company reach an agreement on the Phase III pivotal trial protocol design, clinical endpoints, and statistical analyses that are acceptable to support regulatory approval.
An SPA is binding upon the FDA and the sponsor unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun.