TURKU, Finland, May 25, 2015 (GLOBE NEWSWIRE) -- 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".
Turku, 25 May 2015
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About tozadenant (SYN115)
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist being developed for the treatment of Parkinson's disease. Tozadenant has displayed clinically relevant and statistically significant effects in Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420 patient Phase 2b study. Full data from the study were published in Lancet Neurology in July 2014, and it is expected that this successful study will be accepted as one of the two pivotal studies required for registration in the United States. Tozadenant is currently transitioning into Phase 3 development as part of Biotie's proprietary portfolio.
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie's development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson's disease, which is transitioning into Phase 3 development, and two additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
Source: Biotie Therapies Oyj