Predix Pharmaceuticals announced that under the special protocol assessment (SPA) process, it has reached final agreement with the FDA on the design and statistical analysis plan of a Phase III study for PRX-00023, its 5-HT1A agonist and lead product candidate, to treat generalized anxiety disorder (GAD).

The trial will be an eight-week, double-blind, placebo-controlled, multicenter study. It includes approximately 20 sites in the U.S. and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by a dose of 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD.