PREDIX INITIATES PHASE III TRIAL FOR GENERALIZED ANXIETY DISORDER
Predix Pharmaceuticals has announced the initiation of its first Phase III trial of PRX-00023, a 5-HT1A agonist, in patients with generalized anxiety disorder (GAD).
This Phase III study follows the recent completion of a Phase II study of PRX-00023 in patients with GAD. The Phase II study was an open-label, multicenter outpatient trial in 20 patients with the diagnosis of moderate-to-severe GAD at study entry. The primary objective was to assess the safety and tolerability of PRX-00023 during short-term treatment of patients with GAD. Following a one-week, single-blinded placebo run-in period, PRX-00023 was administered to patients in doses of 40 mg once daily orally for four days, followed by 80 mg once daily orally for 10 days and then 120 mg once daily orally for 14 days. The most frequently reported adverse event was flu-like symptoms, occurring in three patients. There were no serious adverse events or drug-related adverse events leading to discontinuation in the study.