Predix progresses anxiety drug to late stage trial

The company is currently in discussions with the Food and Drug Administration in order to finalize the details of this trial. The FDA has made recommendations regarding secondary endpoint selection which the company says it has now adopted. The FDA has also requested that the company produce a detailed statistical analysis plan of this study, which the company is now compiling.

This Phase III study follows the recent completion of a Phase II study of PRX-00023 in patients with generalized anxiety disorder. In the phase II study 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.

Although this trial was not designed to demonstrate statistical significance, the company says that preliminary results from the trial were encouraging.

Dr Stephen Donahue, vice president of clinical and regulatory affairs added, “Our goal in this program is to develop PRX-00023 as a once-daily drug to treat anxiety and depression with no sexual side effects and with a rapid onset of action. We are very pleased with the initial safety and efficacy data from our Phase I and II trials.”