anxiety disorders, panic disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder
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Always consult your own doctor if you are in any way concerned about your health.
Yul Brynner
Last Reset: 03:05, 14 May 06
Predix Pharmaceuticals announced today that a Phase II clinical trial of its lead drug candidate, PRX-00023, showed significantly reduced symptoms and was well-tolerated in the 21 patients with generalized anxiety disorder (GAD) participating in the four-week, open-label study. The results are being presented at the 46th Annual New Clinical Drug Evaluation Unit (NCDEU) meeting in Boca Raton, Fla.
A Phase III clinical trial is ongoing with PRX-00023, and the results from that study will provide further clinical insight into the efficacy and tolerability of this drug candidate in generalized anxiety.
The Phase II data showed the GAD patients enrolled in the study had significantly reduced GAD symptoms from day 1, including the Hamilton Anxiety Rating Scale (HAM-A). Six of the 19 patients (32%) with week 4 evaluations achieved remission criteria based on the HAM-A, and 52% had a 50% or greater reduction in the HAM-A total scale. Patients had a diagnosis of GAD, HAM-A screening scores of 20 or greater when they entered the study, and had stopped taking other medicines for the treatment of anxiety.
The drug is also being tested in an ongoing late-stage, or Phase III, human clinical trial. A drug must successfully complete Phase III clinical trials before it is submitted to the U.S. Food and Drug Administration for marketing approval.
posted Wednesday, 14 June 2006
tags: generalized anxiety disorder prx00023 gad