TURKU, Finland I May 25, 2015 I Biotie Therapies has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 study of tozadenant in Parkinson’s disease (PD). The Phase 3 study (TOZ-PD) will evaluate efficacy and safety of tozadenant compared to placebo in PD patients taking levodopa and experiencing end-of-dose wearing off.
A Special Protocol Assessment is a written agreement with the FDA on the design, size and planned analysis for a clinical trial. An SPA may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new public health concerns. A positive outcome of TOZ-PD, along with the results of the completed Phase 2b study are expected to be sufficient to support a claim of efficacy for tozadenant in patients with Parkinson’s disease with motor fluctuations (end-of-dose wearing off) and could form the basis of an NDA submission. Final marketing approval will be dependent, amongst other factors, on the overall results of the trial.
The planned study is a randomized, double-blind, placebo controlled Phase 3 study in 450 PD patients experiencing levodopa related end-of-dose wearing off, in which participants will be randomized to receive twice daily doses of 60mg or 120mg of tozadenant or placebo, in addition to their standard anti-PD medications, for 24 weeks. The primary endpoint will be reduction in time spent in the “off” state in patients taking tozadenant as compared to placebo between baseline and week 24. The double-blind phase of the study will be followed by an open-label treatment phase of a one year duration.
Timo Veromaa, President and CEO of Biotie, commented: “The agreement with FDA is another important milestone in our effort to bring tozadenant through the regulatory process and make it available to patients to address a significant unmet medical need”.
SOURCE: Biotie Therapies
Post Views: 213
TURKU, Finland I May 25, 2015 I Biotie Therapies has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 study of tozadenant in Parkinson’s disease (PD). The Phase 3 study (TOZ-PD) will evaluate efficacy and safety of tozadenant compared to placebo in PD patients taking levodopa and experiencing end-of-dose wearing off.
A Special Protocol Assessment is a written agreement with the FDA on the design, size and planned analysis for a clinical trial. An SPA may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new public health concerns. A positive outcome of TOZ-PD, along with the results of the completed Phase 2b study are expected to be sufficient to support a claim of efficacy for tozadenant in patients with Parkinson’s disease with motor fluctuations (end-of-dose wearing off) and could form the basis of an NDA submission. Final marketing approval will be dependent, amongst other factors, on the overall results of the trial.
The planned study is a randomized, double-blind, placebo controlled Phase 3 study in 450 PD patients experiencing levodopa related end-of-dose wearing off, in which participants will be randomized to receive twice daily doses of 60mg or 120mg of tozadenant or placebo, in addition to their standard anti-PD medications, for 24 weeks. The primary endpoint will be reduction in time spent in the “off” state in patients taking tozadenant as compared to placebo between baseline and week 24. The double-blind phase of the study will be followed by an open-label treatment phase of a one year duration.
Timo Veromaa, President and CEO of Biotie, commented: “The agreement with FDA is another important milestone in our effort to bring tozadenant through the regulatory process and make it available to patients to address a significant unmet medical need”.
SOURCE: Biotie Therapies
Post Views: 213
