FDAnews
www.fdanews.com/articles/68164-durect-completes-enrollment-for-durin-based-leuprolide-product-trial

Durect Completes Enrollment for DURIN-Based Leuprolide Product Trial

January 31, 2005

Durect and Voyager Pharmaceutical have completed enrollment for the recently approved study for the DURIN-based leuprolide acetate product candidate for Alzheimer's disease under development by the parties (the DURIN-leuprolide implant).

The FDA accepted Voyager's investigational new drug application and clinical protocol in late December 2004, and this unique formulation is being used in the present study in healthy volunteers to evaluate the product candidate's bioavailability, as well as determine its safety and tolerability following administration. Voyager has completed the enrollment and initial dosing of all screened subjects necessary to complete the trial.